UCB (EBR:UCB) UCB Media Room: Vimpat FDA PGTCS Approval

Transparency directive : regulatory news

17/11/2020 13:04

https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUb513= 9PTmAm2ORJ-2Fb7C-2B6ekXZPmBWFtP0rVrju1GvxkNwTvJQwMncVll2kBwJnfoVA5DyBr-2FOT= S8ZCG6ASqlWtRLuD-2Bk3UCdnKaCItUZHs17l1p6_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVW= u7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9= g1wZPvJvi2YsdQZamHGhYuEzl4Usm6hVrmsd2niIXYTCuRdJelcIVHq7IOaqqPnxiZGLwII9toV= QV72nvCRk-2B7PiNVSdSuZSakC4jmdU5usLcTYQW4JHSBJABtjsdhPW8kewkPdTpZv811bXGnbv= IICX3yHk6lrA02tV-2FZVE4sfuTPlFcLybciLWJwjN5OqYZaOMJpZIQDrROvBZfvsjobdECit2h= 0k6QHTgXpz1KIZnge8f5H-2FeVoe9dxpUPt-2B9LspA-3D ** UCB=E2=80=99s VIMPAT^=C2=AE (lacosamide) CV now approved by FDA in U.S. = for primary generalized tonic-clonic seizures and expanded pediatric use fo= r people living with epilepsy ------------------------------------------------------------ =C2=B7 New approval for VIMPAT^=C2=AE (lacosamide) CV in the U.S. as adjunc= tive therapy in the treatment of primary generalized tonic-clonic seizures = (PGTCS) in patients four years of age and older=C2=A0 =C2=B7 All three VIMPAT formulations, including injection for intravenous u= se, are now indicated for the treatment of partial-onset seizures and as ad= junctive therapy in the treatment of PGTCS in patients four years of age an= d older=C2=A0 =C2=B7 These approvals further help patients with epilepsy who may have had= limited treatment options in the past, while reinforcing UCB=E2=80=99s lea= dership in transforming epilepsy care =C2=B7 In October, the Committee for Medicinal Products for Human Use (CHMP= ) of the European Medicines Agency (EMA) issued a positive opinion for VIMP= AT as adjunctive therapy in the treatment of PGTCS in adults, adolescents a= nd children from four years of age with idiopathic generalized epilepsy Brussels, Belgium, Atlanta, Ga., November 17, 2020: UCB, a global pharmaceu= tical company, today announced that the U.S. Food and Drug Administration (= FDA) has approved VIMPAT=C2=AE (lacosamide) CV as adjunctive therapy in the= treatment of primary generalized tonic-clonic seizures (PGTCS) in patients= four years of age and older and VIMPAT injection for intravenous use in ch= ildren four years of age and older.^1 PGTCS is a type of seizure that occur= s all over the brain, affecting both sides of the brain from the start, cau= sing muscles to stiffen and convulsions to occur for up to a few minutes.^2 =E2=80=9CThese approvals underscore UCB=E2=80=99s commitment to people livi= ng with epilepsy and our focus on finding solutions for specific unmet need= s within the epilepsy community.=E2=80=9D said Mike Davis, Head of U.S. Neu= rology at UCB. =E2=80=9CWe are pleased that VIMPAT is now available as a tr= eatment option for people living with primary generalized tonic-clonic seiz= ures on their journey to seizure control.=E2=80=9D The PGTCS approval is based, in part, on results of a Phase 3 study recentl= y published in the Journal of Neurology, Neurosurgery & Psychiatry.^3 =C2= =A0Adjunctive treatment with VIMPAT resulted in a significantly lower risk = of developing a second PGTCS during the 24-week treatment period, with the = corresponding risk reduction being 45% (p=3D0.001), and a significantly hig= her rate of freedom from PGTCS during the treatment period compared with pl= acebo (31.3% vs 17.2%, p=3D0.011).^1=C2=A0 People living with generalized tonic-clonic seizures have an increased risk= of injury^4 and those who experienced three or more in one year had a fift= een-fold increased risk of sudden unexpected death in epilepsy.^5 =E2=80=9CThe treatment of primary generalized tonic-clonic (convulsive) sei= zures is challenging, with about one-third of patients still being refracto= ry while on therapy,=E2=80=9D said David Vossler, MD, FAAN FACNS FAES, Depa= rtment of Neurology, University of Washington, Seattle, USA. =E2=80=9CBolst= ered by a wealth of data demonstrating VIMPAT=E2=80=99s efficacy and safety= , this new indication gives people suffering from PGTCS a chance at freedom= from these seizures, which many have never experienced.=E2=80=9D Results from the Phase 3 study showed that VIMPAT was generally tolerated i= n patients with idiopathic generalised epilepsy (IGE) and PGTCS. The most c= ommon adverse reactions (=E2=89=A510%) reported in patients treated with VI= MPAT were dizziness (23%), somnolence (17%), headache (14%), and nausea (10= %) compared to 7%, 14%, 10%, and 6%, respectively, of patients who received= placebo.^1 Regarding the expanded pediatric population, VIMPAT tablets and oral soluti= on were already approved to treat partial-onset seizures in adults and chil= dren four years and older as monotherapy and adjunctive therapy. In the US,= VIMPAT injection was previously approved for the treatment of partial-onse= t seizures only in adult patients (17 years of age and older). In Europe VIMPAT is currently not indicated in patients with PGTCS, however= , in October =C2=A02020, the Committee for Medicinal Products for Human Use= (CHMP) of the European Medicines Agency (EMA) issued a positive opinion fo= r VIMPAT as adjunctive therapy in the treatment of PGTCS in adults, adolesc= ents and children from four years of age with idiopathic generalized epilep= sy.^6 Regulatory reviews for use of VIMPAT in the treatment of PGTCS are al= so underway in the Japan and Australia. About Epilepsy Epilepsy is the main symptom of a variety of chronic disorders of the brain= . It is the fourth most common neurological condition worldwide and affects= approximately 65 million people. Anyone can develop epilepsy; it occurs ac= ross all ages, races and genders, and is defined as one or more unprovoked = epileptic seizures with a risk of further seizures.^7 About UCB in Epilepsy UCB has a rich heritage in epilepsy with over 20 years of experience in the= research and development of anti-epileptic drugs. As a company with a long= -term commitment to epilepsy research, our goal is to address unmet medical= needs. Our scientists are proud to contribute to advances in the understan= ding of epilepsy and its treatment. We partner and create super-networks wi= th world-leading scientists and clinicians in academic institutions, pharma= ceutical companies, and other organizations who share our goals. At UCB, we= are inspired by patients, and driven by science in our commitment to suppo= rt patients with epilepsy. About UCB=C2=A0 UCB, Brussels, Belgium (www.ucb-usa.com) is a global biopharmaceutical comp= any focused on the discovery and development of innovative medicines and so= lutions to transform the lives of people living with severe diseases of the= immune system or the central nervous system. With more than 7,600 people i= n approximately 40 countries, the company generated revenue of =E2=82=AC4.9= billion in 2019. UCB is listed on Euronext Brussels (symbol: UCB). Follow = us on Twitter: @UCBUSA. About VIMPAT^=C2=AE (lacosamide) CV in the U.S.^1 VIMPAT^=C2=AE was approved in the U.S. in 2008 as an add-on therapy for the= treatment of partial-onset seizures in adult patients with epilepsy. VIMPA= T was approved as monotherapy for adults in August 2014, and as monotherapy= or adjunctive therapy in patients four years of age and older with partial= -onset seizures in 2017. VIMPAT is available in three formulations: oral ta= blets, oral solution, and intravenous (IV) injection.=C2=A0 INDICATION=C2=A0 VIMPAT^=C2=AE is indicated for the treatment of partial-onset seizures in p= atients 4 years of age and older.=C2=A0 VIMPAT is indicated as adjunctive therapy in the treatment of primary gener= alized tonic-clonic seizures in patients 4 years of age and older.=C2=A0 IMPORTANT SAFETY INFORMATION=C2=A0 WARNINGS AND PRECAUTIONS=C2=A0 =C2=B7 Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), includin= g VIMPAT, increase the risk of suicidal behavior and ideation. Monitor pati= ents taking VIMPAT for the emergence or worsening of depression, suicidal t= houghts or behavior, and/or any unusual changes in mood or behavior. Advise= patients and caregivers to be alert for these behavioral changes and to im= mediately report them to the healthcare provider.=C2=A0 =C2=B7 Dizziness and Ataxia: VIMPAT may cause dizziness and ataxia in adult= and pediatric patients. In adult clinical trials for partial-onset seizure= s, the onset of dizziness and ataxia was most commonly observed during titr= ation. Advise patients not to drive, operate complex machinery, or engage i= n other hazardous activities until they are familiar with the effects of VI= MPAT on their ability to perform such activities.=C2=A0 =C2=B7 Cardiac Rhythm and Conduction Abnormalities PR Interval Prolongation, Atrioventricular Block, and Ventricular Tachyarrh= ythmia=C2=A0 Dose-dependent prolongations in PR interval with VIMPAT have been observed = in clinical studies in adult patients and in healthy volunteers. When VIMPA= T is given with other drugs that prolong the PR interval, further PR prolon= gation is possible.=C2=A0 In the postmarketing setting, there have been reports of cardiac arrhythmia= s in patients treated with VIMPAT, including bradycardia, AV block, and ven= tricular tachyarrhythmia, which have rarely resulted in asystole, cardiac a= rrest, and death. Most, although not all, cases have occurred in patients w= ith underlying proarrhythmic conditions, or in those taking concomitant med= ications that affect cardiac conduction or prolong the PR interval. These e= vents have occurred with both oral and intravenous routes of administration= and at prescribed doses as well as in the setting of overdose.=C2=A0 VIMPAT should be used with caution in patients with underlying proarrhythmi= c conditions such as known cardiac conduction problems (e.g., marked first-= degree AV block, second-degree or higher AV block, and sick sinus syndrome = without pacemaker), severe cardiac disease (such as myocardial ischemia or = heart failure, or structural heart disease), and cardiac sodium channelopat= hies (e.g., Brugada Syndrome).=C2=A0 VIMPAT should also be used with caution in patients on concomitant medicati= ons that affect cardiac conduction, including sodium channel blockers, beta= -blockers, calcium channel blockers, potassium channel blockers, and medica= tions that prolong the PR interval. In such patients, obtaining an ECG befo= re beginning VIMPAT, and after VIMPAT is titrated to steady-state maintenan= ce dose, is recommended. In addition, these patients should be closely moni= tored if they are administered VIMPAT through the intravenous route. Patien= ts should be made aware of and report cardiac signs or symptoms to their he= althcare provider right away.=C2=A0 Atrial Fibrillation and Atrial Flutter=C2=A0 VIMPAT administration may predispose to atrial arrhythmias (atrial fibrilla= tion or flutter), especially in patients with diabetic neuropathy and/or ca= rdiovascular disease.=C2=A0 =C2=B7 Syncope: VIMPAT may cause syncope in adult and pediatric patients.= =C2=A0 =C2=B7 Withdrawal of Antiepileptic Drugs: Gradually withdraw VIMPAT (over a= minimum of 1 week) to minimize the potential of increased seizure frequenc= y.=C2=A0 =C2=B7 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Also = known as multi- organ hypersensitivity, has been reported with antiepilepti= c drugs, including VIMPAT. Some of these events have been fatal or life-thr= eatening. If signs or symptoms are present, immediately evaluate the patien= t. Discontinue VIMPAT if an alternative etiology for the signs and symptoms= cannot be established.=C2=A0 =C2=B7 Risks in Patients with Phenylketonuria: VIMPAT oral solution contain= s aspartame, a source of phenylalanine, which can be harmful in patients wi= th phenylketonuria (PKU). A 200 mg dose of VIMPAT oral solution (equivalent= to 20 mL) contains 0.32 mg of phenylalanine.=C2=A0 Adverse Reactions=C2=A0 =C2=B7 Partial-Onset Seizures: In the adult adjunctive therapy placebo-cont= rolled clinical trials for partial-onset seizures, the most frequently seen= adverse reaction with VIMPAT was dizziness (31% vs 8% placebo). Other comm= on adverse reactions occurring in =E2=89=A510 percent of VIMPAT-treated pat= ients, and greater than placebo, were headache, nausea, and diplopia. In th= e adult monotherapy clinical trial, adverse reactions were generally simila= r to those observed and attributed to drug in adjunctive placebo-controlled= trials, with the exception of insomnia (observed at a higher rate of =E2= =89=A52%). =C2=B7 Primary Generalized Tonic-Clonic Seizures: In the adjunctive therapy= placebo-controlled trial for primary generalized tonic-clonic seizures, th= e adverse reactions were generally similar to those that occurred in the pa= rtial-onset seizure placebo-controlled trials. The adverse reactions most c= ommonly reported were dizziness, somnolence, headache, and nausea. =C2=B7 Pediatric patients: Adverse reactions reported in clinical studies o= f pediatric patients 4 to less than 17 years of age were similar to those s= een in adult patients.=C2=A0 =C2=B7 Injection: In adult adjunctive therapy clinical trials for partial-o= nset seizures, adverse reactions with intravenous administration generally = were similar to those that occurred with the oral formulation, although int= ravenous administration was associated with local adverse reactions such as= injection site=C2=A0pain or discomfort (2.5%), irritation (1%), and erythe= ma (0.5%). When administering a loading dose, the incidence of CNS adverse = reactions, such as dizziness, somnolence, and paresthesia, may be higher wi= th 15-minute administration than over a 30- to 60-minute period. The advers= e reactions associated with VIMPAT injection in adult patients with primary= generalized tonic-clonic seizures are expected to be similar to those seen= in adults with partial-onset seizures. The adverse reactions associated wi= th VIMPAT injection in pediatric patients are expected to be similar to tho= se noted in adults. Infusion times less than 30 minutes were not adequately= studied in pediatric patients. VIMPAT is a Schedule V controlled substance.=C2=A0 Please refer to full Prescribing Information (https://u7061146.ct.sendgrid.= net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUYoFyLxIH6NTfIHQz376UfJW-2FsDHqKRY= Sd8vhuBQ5YppCe7Iv0JedjEdbLntwziLKRbuwKd1C3IKP7cluI-2FLQn8-3DP4Jo_xDPID0vOuy= lFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf= -2FOeoCOG9ekocVj-2F2X9c9g1wZPvJvi2YsdQZamHGhYuEzl4Usm6hVrmsd2niIXYTCuRdJelc= IVHq7IOaqqPnxiZGLwII9toVQV72nvCRk-2B7PiNVSdSuZSakC4jmdU5usLcTf0igKi3v3dj1e-= 2FubN7-2Bvekjt3-2BAn3B-2BVudgvbJ09dNesQgNr5MaNa8FuzpsFZtly8rGU6SfZ2PR0r72yh= F4gy74w41Ytup-2FaYZnHIKI-2BWQQhPsX9ICdA5yOaPkF9AWxRqQ-2Fvv1C04Nm71c0L19KAIo= -3D . About VIMPAT^=C2=AE =C2=A0in the EU=C2=A0 VIMPAT^=C2=AE was first launched in the European Union in September 2008, a= s adjunctive therapy for the treatment of partial-onset seizures with or wi= thout secondary generalization in adult and adolescent (16-18 years) patien= ts with epilepsy.=C2=A0 In countries of the EU, VIMPAT^=C2=AE is available as film-coated tablets, = syrup and solution for infusion. Lacosamide solution for infusion is an alt= ernative for patients when oral administration is temporarily not feasible.= =C2=A0=C2=A0 Important Safety Information about VIMPAT^=C2=AE in the EU and EEA^8 =C2=A0 VIMPAT^=C2=AE is indicated as monotherapy and adjunctive therapy in the tre= atment of partial-onset seizures with or without secondary generalisation i= n adults, adolescents and children from 4 years of age with epilepsy. VIMPA= T^=C2=AE therapy can be initiated with either oral or IV administration. Fo= r the paediatric population, the physician should prescribe the most approp= riate formulation and strength according to weight and dose. A single loadi= ng dose may be initiated in patients in situations when the physician deter= mines that rapid attainment of lacosamide steady state plasma concentration= and therapeutic effect is warranted. It should be administered under medic= al supervision with consideration of the potential for increased incidence = of serious cardiac arrhythmia and CNS adverse reactions. Administration of = a loading dose has not been studied in acute conditions such as status epil= epticus. Use of a loading dose is not recommended in adolescents and childr= en weighing less than 50 kg. Administration of a loading dose has not been = studied in children. A maximum dose of 300 mg/day is recommended for paedia= tric patients with mild to moderate hepatic impairment weighing 50 kg or mo= re and for adult patients with mild to moderate hepatic impairment as well.= =C2=A0Based on data in adults, in paediatric patients weighing less than 5= 0 kg with mild to moderate hepatic impairment, a reduction of 25 % of the m= aximum dose should be applied. Lacosamide should be administered to adult a= nd paediatric patients with severe hepatic impairment only when the expecte= d therapeutic benefits are anticipated to outweigh the possible risks. The = dose may need to be adjusted while carefully observing disease activity and= potential side effects in the patient. In adolescents and adults weighing = 50 kg or more with mild to moderate hepatic impairment a loading dose of 20= 0mg may be considered, but further dose titration (>200 mg daily) should be= performed with caution. In paediatric patients weighing 50 kg or more and = in adult patients with mild or moderate renal impairment a loading dose of = 200 mg may be considered, but further dose titration (> 200 mg daily) shoul= d be performed with caution. In paediatric patients weighing 50 kg or more = and in adult patients with severe renal impairment (CLCR =E2=89=A4 30 ml/mi= n) or with end-stage renal disease, a maximum dose of 250 mg/day is recomme= nded and the dose titration should be performed with caution. In paediatric= patients weighing less than 50 kg with severe renal impairment (CLCR =E2= =89=A4 30 ml/min) and in those with end-stage renal disease, a reduction of= 25 % of the maximum dose is recommended. Contraindications: Hypersensitivi= ty to the active substance or any of the excipients; known second- or third= -degree atrioventricular (AV) block. Special warnings and precautions for u= se: Treatment with VIMPAT=C2=AE has been associated with dizziness which co= uld increase the occurrence of accidental injury or falls. Therefore, patie= nts should be advised to exercise caution until they are familiar with the = potential effects of the medicine. Dose-related prolongations in PR interva= l with VIMPAT^=C2=AE have been observed in clinical studies. =C2=A0VIMPAT^= =C2=AE should be used with caution in patients with underlying proarrhythmi= c conditions such as patients with known cardiac conduction problems or sev= ere cardiac disease (e.g. myocardial ischaemia/infarction, heart failure, s= tructural heart disease or cardiac sodium channelopathies) or patients trea= ted with medicinal products affecting cardiac conduction, including antiarr= hythmics and sodium channel blocking antiepileptic medicinal products, as w= ell as in elderly patients. In these patients it should be considered to pe= rform an ECG before a Vimpat dose increase above 400mg/day and after Vimpat= is titrated to steady-state. In the placebo-controlled trials of VIMPAT^= =C2=AE in epilepsy patients, atrial fibrillation or flutter were not report= ed; however both have been reported in open-label epilepsy trials and in po= st-marketing experience. In post-marketing experience, AV block (including = second degree or higher AV block) has been reported. In patients with proar= rhythmic conditions, ventricular tachyarrhythmia has been reported. In rare= cases, these events have led to asystole, cardiac arrest and death in pati= ents with underlying proarrhythmic conditions. Patients should be made awar= e of the symptoms of cardiac arrhythmia (e.g. slow, rapid or irregular puls= e, palpitations, shortness of breath, feeling lightheaded, fainting). Patie= nts should be counselled to seek immediate medical advice if these symptoms= occur. Suicidal ideation and behaviour have been reported in patients trea= ted with antiepileptic medicinal products in several indications. Therefore= patients should be monitored for signs of suicidal ideation and behaviours= and appropriate treatment should be considered. Patients (and caregivers o= f patients) should be advised to seek medical advice should signs of suicid= al ideation or behaviour emerge. The safety and efficacy of lacosamide in p= aediatric patients with epilepsy syndromes in which focal and generalised s= eizures may coexist have not been determined. VIMPAT^=C2=AE syrup contains = sodium methyl parahydroxybenzoate (E219) which may cause allergic reactions= (possibly delayed). Vimpat Syrup contains sorbitol (E420). Patients with r= are hereditary problems of fructose intolerance should not take this medici= ne. Sorbitol may cause gastrointestinal discomfort and mild laxative effect= .The syrup contains aspartame (E951), a source of phenylalanine, which may = be harmful for people with phenylketonuria. Vimpat syrup contains propylene= glycol (E1520). VIMPAT=C2=AE syrup contains 1.42 mg sodium per ml, equival= ent to 0.07 % of the WHO recommended maximum daily intake of 2 g sodium for= an adult. VIMPAT=C2=AE solution for infusion contains 59.8 mg sodium per v= ial, equivalent to 3% of the WHO recommended maximum daily intake of 2 g so= dium for an adult. Effects on ability to drive and use machines: VIMPAT=C2= =AE may have minor to moderate influence on the ability to drive and use ma= chines. VIMPAT=C2=AE treatment has been associated with dizziness or blurre= d vision. Accordingly patients should be advised not to drive a car or to o= perate other potentially hazardous machinery until they are familiar with t= he effects of VIMPAT=C2=AE on their ability to perform such activities. Und= esirable effects: The most common adverse reactions (=E2=89=A510%) are dizz= iness, headache, diplopia, and nausea. They were usually mild to moderate i= n intensity. Some were dose-related and could be alleviated by reducing the= dose. Incidence and severity of CNS and gastrointestinal (GI) adverse reac= tions usually decreased over time. Incidence of CNS adverse reactions such = as dizziness may be higher after a loading dose. Other common adverse react= ions (=E2=89=A51% - <10%) are depression, confusional state, insomnia, bala= nce disorder, memory impairment, cognitive disorder, somnolence, tremor, ny= stagmus, hypoesthesia, dysarthria, disturbance in attention, paraesthesia, = vision blurred, vertigo, tinnitus, vomiting, constipation, flatulence, dysp= epsia, dry mouth, diarrhoea, pruritus, rash, muscle spasms, gait disturbanc= e, asthenia, fatigue, irritability, feeling drunk, injection site pain or d= iscomfort (local adverse events associated with intravenous administration)= , irritation (local adverse events associated with intravenous administrati= on), fall, and skin laceration, contusion. The use of VIMPAT=C2=AE is assoc= iated with dose-related increase in the PR interval. Adverse reactions asso= ciated with PR interval prolongation (e.g. atrioventricular block, syncope,= bradycardia) may occur. The safety profile of lacosamide in placebo-contro= lled and in open-label studies (n=3D408) in adjunctive therapy in children = from 4 years of age was consistent with the safety profile observed in adul= ts although the frequency of some adverse reactions (somnolence, vomiting a= nd convulsion) was increased and additional adverse reactions (nasopharyngi= tis, pyrexia, pharyngitis, decreased appetite, lethargy and abnormal behavi= our) have been reported in paediatric patients: nasopharyngitis (15.7 %), v= omiting (14.7 %), somnolence (14.0 %), dizziness (13.5 %), pyrexia (13.0 %)= , convulsion (7.8 %), decreased appetite (5.9 %), pharyngitis (4.7 %), leth= argy (2.7 %) and abnormal behaviour (1.7 %).=C2=A0 Laboratory abnormalities: Abnormalities in liver function tests have been o= bserved in placebo-controlled trials with VIMPAT=C2=AE in adult patients wi= th partial-onset seizures who were taking 1-3 concomitant antiepileptic med= icinal products. Elevations of ALT to =E2=89=A53xULN occurred in 0.7% (7/93= 5) of VIMPAT=C2=AE patients and 0% (0/356) of placebo patients. Multiorgan = Hypersensitivity Reactions: Multiorgan hypersensitivity reactions (also kno= wn as Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS) have be= en reported in patients treated with some antiepileptic medicinal products.= These reactions are variable in expression but typically present with feve= r and rash and can be associated with involvement of different organ system= s. If multiorgan hypersensitivity reaction is suspected, VIMPAT=C2=AE shoul= d be discontinued.=C2=A0 Refer to the European Summary of Product Characteristics for other adverse = reactions and full prescribing information. Date of revision: 03 Sept 2019. https://u7061146.ct.sendgrid.net/ls/click?u= pn=3DTeZUXWpUv-2B6TCY38pVLo9jARV652O70bxLkiVOQ6QQFahA5Xwez108R4QsYcBv0pLEng= _xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2= FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZPvJvi2YsdQZamHGhYuEzl4Usm6hVrmsd2niI= XYTCuRdJelcIVHq7IOaqqPnxiZGLwII9toVQV72nvCRk-2B7PiNVSdSuZSakC4jmdU5usLcTbAA= YihuarygP1YEKGRhm3vX18M116k0s-2FKGUZ8D-2BNyvaQPkBB2nUfEmhYnPWNCns77mWS2J0en= uVwS3MuIwjwd6lOqYoyJAq-2FYWU4gpCnT1BHlPPUf-2B-2BJkKfZRCvZw5HhSDdsA6OYsimDXl= 4EARDv0-3D For further information, UCB: U.S. Neurology Communications Erica Puntel U.S. Communications, UCB T 404.938.5359, erica.puntel@ucb.com =C2=A0=C2=A0 Investor Relations Antje Witte, Investor Relations, UCB =C2=A0=C2=A0 T +32.2.559.94.14, antje.witte@ucb.com =C2=A0=C2=A0 Isabelle Ghellynck, Investor Relations, UCB T+32.2.559.9588, isabelle.ghellynck@ucb.com=C2=A0 ### VIMPAT^=C2=AE is a registered trademark used under license from Harris FRC = Corporation. Forward looking statements =E2=80=93 UCB This press release contains forward-looking statements including, without l= imitation, statements containing the words =E2=80=9Cbelieves=E2=80=9D, =E2= =80=9Canticipates=E2=80=9D, =E2=80=9Cexpects=E2=80=9D, =E2=80=9Cintends=E2= =80=9D, =E2=80=9Cplans=E2=80=9D, =E2=80=9Cseeks=E2=80=9D, =E2=80=9Cestimate= s=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccontinu= e=E2=80=9D and similar expressions. These forward-looking statements are ba= sed on current plans, estimates and beliefs of management. All statements, = other than statements of historical facts, are statements that could be dee= med forward-looking statements, including estimates of revenues, operating = margins, capital expenditures, cash, other financial information, expected = legal, arbitration, political, regulatory or clinical results or practices = and other such estimates and results. By their nature, such forward-looking= statements are not guarantees of future performance and are subject to kno= wn and unknown risks, uncertainties and assumptions which might cause the a= ctual results, financial condition, performance or achievements of UCB, or = industry results, to differ materially from those that may be expressed or = implied by such forward-looking statements contained in this press release.= Important factors that could result in such differences include: changes i= n general economic, business and competitive conditions, the inability to o= btain necessary regulatory approvals or to obtain them on acceptable terms = or within expected timing, costs associated with research and development, = changes in the prospects for products in the pipeline or under development = by UCB, effects of future judicial decisions or governmental investigations= , safety, quality, data integrity or manufacturing issues; potential or act= ual data security and data privacy breaches, or disruptions of our informat= ion technology systems, product liability claims, challenges to patent prot= ection for products or product candidates, competition from other products = including biosimilars, changes in laws or regulations, exchange rate fluctu= ations, changes or uncertainties in tax laws or the administration of such = laws, and hiring and retention of its employees. There is no guarantee that= new product candidates will be discovered or identified in the pipeline, o= r that new indications for existing products will be developed and approved= . Movement from concept to commercial product is uncertain; preclinical res= ults do not guarantee safety and efficacy of product candidates in humans. = So far, the complexity of the human body cannot be reproduced in computer m= odels, cell culture systems or animal=C2=A0models. The length of the timing= to complete clinical trials and to get regulatory approval for product mar= keting has varied in the past and UCB expects similar unpredictability goin= g forward. Products or potential products which are the subject of partners= hips, joint ventures or licensing collaborations may be subject to disputes= between the partners or may prove to be not as safe, effective or commerci= ally successful as UCB may have believed at the start of such partnership. = UCB=E2=80=99 efforts to acquire other products or companies and to integrat= e the operations of such acquired companies may not be as successful as UCB= may have believed at the moment of acquisition. Also, UCB or others could = discover safety, side effects or manufacturing problems with its products a= nd/or devices after they are marketed. The discovery of significant problem= s with a product similar to one of UCB=E2=80=99s products that implicate an= entire class of products may have a material adverse effect on sales of th= e entire class of affected products. Moreover, sales may be impacted by int= ernational and domestic trends toward managed care and health care cost con= tainment, including pricing pressure, political and public scrutiny, custom= er and prescriber patterns or practices, and the reimbursement policies imp= osed by third-party payers as well as legislation affecting biopharmaceutic= al pricing and reimbursement activities and outcomes. Finally, a breakdown,= cyberattack or information security breach could compromise the confidenti= ality, integrity and availability of UCB=E2=80=99s data and systems.=C2=A0 Given these uncertainties, you should not place undue reliance on any of su= ch forward-looking statements. There can be no guarantee that the investiga= tional or approved products described in this press release will be submitt= ed or approved for sale or for any additional indications or labelling in a= ny market, or at any particular time, nor can there be any guarantee that s= uch products will be or will continue to be commercially successful in the = future. UCB is providing this information, including forward-looking statements, on= ly as of the date of this press release and expressly disclaims any duty to= update any information contained in this press release, either to confirm = the actual results or to report or reflect any change in its forward-lookin= g statements with regard thereto or any change in events, conditions or cir= cumstances on which any such statement is based, unless such statement is r= equired pursuant to applicable laws and regulations.=C2=A0 Additionally, information contained in this document shall not constitute a= n offer to sell or the solicitation of an offer to buy any securities, nor = shall there be any offer, solicitation or sale of securities in any jurisdi= ction in which such offer, solicitation or sale would be unlawful prior to = the registration or qualification under the securities laws of such jurisdi= ction. References: 1. VIMPAT^=C2=AE (lacosamide) CV. U.S. Prescribing Information 2. NIHR: National Institute for Health Research. Lacosamide for primary gen= eralised tonic-clonic seizures =E2=80=93 adjunctive therapy. https://u70611= 46.ct.sendgrid.net/ls/click?upn=3DTeZUXWpUv-2B6TCY38pVLo9hKxrrH2Rlz-2BFT4eh= EaB3hC3QIzjC61puTNHOo8dTsFMr7oPqP-2Bs9Yp3Eih3qBy3A9ZycqySPuXGknvBDLJHu2ywWP= whF4isoDPzcN98gpE8SDJlK3EbtNr2eIkn4DkHkn712KvKsLTMEWWC5STylU3pPrgYd9HQqEZ4K= ztV4LLEkBG4oI1n9-2FUjBvXQSVf0OQ-3D-3Dsokf_xDPID0vOuylFAU8fv4e60wei4JxqEGBdV= Wu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c= 9g1wZPvJvi2YsdQZamHGhYuEzl4Usm6hVrmsd2niIXYTCuRdJelcIVHq7IOaqqPnxiZGLwII9to= VQV72nvCRk-2B7PiNVSdSuZSakC4jmdU5usLcTUJyLvJesFEM8UMNZDKYaQu5MfQQ2bdlwlIhwa= 3Po0P-2BjQInWyAfycqiB7fWWdAnoHvTdPaxUxN0qeLd0sB61KxYnjdfg5goWrmrjfGmz6yKP8u= Eqg2kSIeUL3LXUL63YUMb9SfXwRwzNnDE5aTct1w-3D 3. Vossler DG, et al. Efficacy and safety of adjunctive lacosamide in the t= reatment of primary generalised tonic-clonic seizures: a double-blind, rand= omized, placebo-controlled trial. Neurol Neurosurg Psychiatry 2020; 91(10):= 1067-1075 4. Asadi-Pooya AA, Nikseresht A, Yaghoubi E, et al. Physical injuries in pa= tients with epilepsy and their associated risk factors. Seizure 2012;21:165= =E2=80=938. 5 5. DeGiorgio CM, et al. Ranking the leading risk factors for sudden unexpec= ted death in epilepsy. Front Neurol. 2017;8:473 6. European Medicine Agency: Committee for Medicinal Products for Human Use= (CHMP). https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ5= 3jATUdN3EU-2FWvZebf3RrOmE3Tk7A84JoUHkKO-2FT3hulthUdAVAJCI9hDYmvbklauVGkku2m= ofo-2FUyzTSEmJkfFlFF86SEWVWeWO5-2BleZ4D2c3ALUliu7OfUSQoOMTQMkiN-2BsC-2FsKXi= YnZTdJ02E4BaQhXLY-3DvpO7_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46= DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZPvJvi2YsdQZa= mHGhYuEzl4Usm6hVrmsd2niIXYTCuRdJelcIVHq7IOaqqPnxiZGLwII9toVQV72nvCRk-2B7PiN= VSdSuZSakC4jmdU5usLcTbeKOm7C1iy9jDNyWWoOf9UoSWdceh-2B1Mf0s5fB0oSSv8YNo3Iz6h= OwBLRsK-2FzOwf6DFrLU05azyD0PyiMDMlkDQEgvse9OYea3hFKjCE7Q9DeOf77s-2FlKJkDG9W= WNOtU1eTgPxKVlDldgFb9nGMv4U-3D 7. Epilepsy Foundation. Who gets epilepsy? https://u7061146.ct.sendgrid.net= /ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUQCRjRuKbowuneDjH-2BQHr2IU4Az-2BfT1tR= dstijkxTCP6vHMerx3W9w2FdvheqA9v2JT5QNzcftdUJ-2F8dO42FbjE-3DP5sp_xDPID0vOuyl= FAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-= 2FOeoCOG9ekocVj-2F2X9c9g1wZPvJvi2YsdQZamHGhYuEzl4Usm6hVrmsd2niIXYTCuRdJelcI= VHq7IOaqqPnxiZGLwII9toVQV72nvCRk-2B7PiNVSdSuZSakC4jmdU5usLcTbqIK-2Fukget8GE= 0NA9SnsGanLLw2Dt52bb-2FWHUV4bonAFslPHH2MnZUhocQMGbEXjPsyeng6EvLZcBKf-2FVx3Y= AMEB5RdTZZBG0-2BkWFRdL84JI4JUCKhsIGwR7WTw2LcAwYxiOeTl3ZH-2Bbtbw8AQza5k-3D D= ate Accessed 10 November 2020 8. Vimpat (lacosamide) EU Summary of Product Characteristics https://u70611= 46.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUdN3EU-2FWvZebf3RrO= mE3Tk582sCd7B1NxIYr9lhGAtEZw_Tq_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3= b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZPvJvi= 2YsdQZamHGhYuEzl4Usm6hVrmsd2niIXYTCuRdJelcIVHq7IOaqqPnxiZGLwII9toVQV72nvCRk= -2B7PiNVSdSuZSakC4jmdU5usLcTZ-2BPcm3VbxgEk0FmnuOnyJ-2FDOEOcQCq1e4OJEc-2B6iv= ruOOgqEe4P0J03RSICnF20jqstCpUJnM3JakKu3jP9Uknh7gxCYBnDlDFWmshTHAehnfnsLWfA1= fJgus-2FtS-2BniLAqEgrP9azzI60E8GUHPTTg-3D Date Accessed 20 October GenericFile Vimpat PGTCS FDA Approval ENG (https://u7061146.ct.sendgrid.net/ls/click?up= n=3D4tNED-2FM8iDZJQyQ53jATUb5139PTmAm2ORJ-2Fb7C-2B6ekXZPmBWFtP0rVrju1GvxkN9= B90S-2FfmY8xcgr5NoflK1x2tFAwZwUlozoCxm1bpIko-3D7fwi_xDPID0vOuylFAU8fv4e60we= i4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9eko= cVj-2F2X9c9g1wZPvJvi2YsdQZamHGhYuEzl4Usm6hVrmsd2niIXYTCuRdJelcIVHq7IOaqqPnx= iZGLwII9toVQV72nvCRk-2B7PiNVSdSuZSakC4jmdU5usLcTVr-2B9JZPWp4kxjlnnxv6CNylSy= nIKXobueVLPMzUulwriQLKNy3QniWBRwbnWcJmMvDOr7yCM3ZUxrSCvEYogLkenGICMAfqODcwJ= qldL5q5EQs3oDrESMsLcWvx8hgEyrBu73rTcDn2UvOSAoF1O34-3D=0D =0D ______________________=0D If you would rather not receive future communications from UCB SA, please g= o to https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jAT= UeYfdhr1xEBQnaPhR2RKx1tfe2VKDZTewv5u80JomRcXyZaiI-2BqxQmJOZXIMiWNuRmjoIqhpp= KQU4YC2Kr1waid-2FZaTVpYt-2Bp8oAz7QIg1SLYuFvY-2Fjnl9fKSHKG7WTtqjj19h3Lxsi59x= rWkq-2FmH-2FM-3D42RO_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86= bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZPvJvi2YsdQZamHGh= YuEzl4Usm6hVrmsd2niIXYTCuRdJelcIVHq7IOaqqPnxiZGLwII9toVQV72nvCRk-2B7PiNVSdS= uZSakC4jmdU5usLcTXI84hEK-2FMdFSumAIGC-2B3eNdgstqQp4aQI8pMEr4DvYQKzgzvg0vEGw= qTcGO4SKcDTztUY39mc1YP6lRNTZ5gxjBPpfmmyyUuQOvPIcPqtrcGDMMtlngRhy2rgeGw3reEo= 4EEuHJniXEQ6OcV3Pm5qc-3D=0D UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . 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