UCB (EBR:UCB) UCB Media Room: FINTEPLA®▼ (fenfluramine) oral solution approved in Japan for adjunctive treatment of seizures associated with LGS

Transparency directive : regulatory news

17/04/2024 07:01

https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0r= CyBv9bezcPT-2BuItTLKIHepbxTbo-2FYbVFPSBekB-2Bmk9X7Kl8shoTE6BsSbYYjHYcOVCrOC= rjYrJUHPDVbu1NKaBE-3DQQkG_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2= FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLN= n-2B6FohpNoV33rPGQBEWyWjOUwNPK4Z82f-2BDB6SHMwgWrKtDq4JCWyUopircJ6irEZvZRs-2= FZ4Laff9bM-2BNFy2c1s9Es-2B9tLpGKJMHiGf2VX9btJLfjnY72mEZeo5nVxkD8cas7Upy4JxO= TycAOVrPQvqvU3QT97S4SdTxVuqhA93AapwlXJVEgYRi-2FhjUFJ1mndpmHtjVHIzpfVcdwwmBL= v5V-2FWeebHpTcIpXo01eRgtipYuRrfIdT2M-3D ** FINTEPLA^=C2=AE=E2=96=BC (fenfluramine) oral solution approved in Japan = for adjunctive treatment of seizures associated with Lennox-Gastaut syndrom= e (LGS) ------------------------------------------------------------ Brussels, Belgium =E2=80=93 17 April 2024 =E2=80=93 7:00 AM CET=E2=80=93 UC= B=E2=80=99s FINTEPLA^=C2=AE=E2=96=BC (fenfluramine) oral solution has been = approved by the Japanese Ministry of Health, Labour, and Welfare (MHLW) for= the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) as= an add-on therapy to other anti-epileptic medicines for patients two years= of age and older.^1=C2=A0 The approval by the MHLW was based on safety and efficacy data from a globa= l, double-blind, placebo-controlled, parallel-group randomized Phase 3 clin= ical trial (1601 Study Cohort A & B), in 296 patients with LGS (aged 2-35 y= ears), including 33 in Japan. In the Japanese sub-population, adjunctive fe= nfluramine, at a dose of 0.7 mg/kg/day, provided a greater reduction in the= frequency of drop seizures compared to placebo. The most common (=E2=89=A5= 10%) non-cardiovascular treatment=E2=80=93emergent adverse events (TEAEs) w= ere decreased appetite, somnolence, weight decreased, diarrhea, and nasopha= ryngitis. No cases of valvular heart disease or pulmonary arterial hyperten= sion were observed.^2 =E2=80=9CWe know that the unmet needs in Lennox-Gastaut syndrome are great,= and we look forward to bringing this important treatment advancement to pe= ople and families impacted by this condition in Japan. We are working to en= sure that all patients who need our treatments can access them, and this ap= proval further demonstrates that commitment,=E2=80=9D said Mike Davis, Head= of Global Epilepsy & Rare Syndromes, UCB.=C2=A0 =E2=80=9CThis approval is an important milestone for UCB, delivering on our= mission to bring several innovative new medicines to people living with se= vere neurological and immunological diseases in Japan this year, =E2=80=9Cs= aid Kanako Kikuchi, Head of UCB Japan. =E2=80=9CWe would like to thank our = Japanese patients and families for participating in the clinical trials, en= abling families and people impacted by Lennox-Gastaut to have this new trea= tment option.=E2=80=9D Lennox-Gastaut syndrome (LGS) is a childhood-onset severe developmental and= epileptic encephalopathy (DEE), characterized by multiple types of drug-re= sistant seizures, and associated with high morbidity and profound effects o= n the quality of life (QoL) of patients and their families.^3,4 Motor, cogn= itive, and behavioural abnormalities are lifelong, with serious intellectua= l disability worsening over time.^5-9 Seizures leading to falls ("drop atta= cks/seizures") are common in LGS and tonic seizures are a hallmark feature = of this syndrome.^3,4 Among the typical seizures associated with a drop, th= e generalized tonic=E2=80=93clonic seizures (GTCS) are commonly observed an= d usually occur in later stages of LGS but sometimes may precede core seizu= re types. In addition to being associated with bodily injury and hospitaliz= ations, GTC seizures are a primary risk factor of sudden unexpected death i= n epilepsy (SUDEP). Patients with epilepsy with GTC seizures have an approx= imately 10-fold greater risk for SUDEP than patients with other seizure typ= es.^2 Fenfluramine is marketed in Japan by Nippon Shinyaku Co., Ltd. based on the= exclusive sales agreement signed in 2019 between Zogenix Inc., (acquired b= y UCB in 2022) and Nippon Shinyaku Co., Ltd. UCB is the Marketing Authoriza= tion holder. About UCB UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company = focused on the discovery and development of innovative medicines and soluti= ons to transform the lives of people living with severe diseases of the imm= une system or of the central nervous system. With approximately 9,000 peopl= e in approximately 40 countries, the company generated revenue of =E2=82=AC= 5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Fol= low us on Twitter: @UCB_news For further information, contact UCB:=C2=A0 Investor Relations Antje Witte T +32.2.559.94.14=C2=A0 email antje.witte@ucb.com=C2=A0 Corporate Communications Laurent Schots=C2=A0 T +32.2.559.92.64=C2=A0 email laurent.schots@ucb.com Global Communications Nick Francis T +44 7769 307745 email nick.francis@ucb.com =C2=A0 Important Safety Information about FINTEPLA=E2=96=BC (fenfluramine) in the = EU^10 Active Ingredient: Oral solution: 2.2 mg fenfluramine (as fenfluramine hydr= ochloride) per ml.=C2=A0 Indications: Treatment of seizures associated with Dravet syndrome and Lenn= ox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines = for patients 2 years of age and older.=C2=A0 Dosage and Administration: Please refer to SmPC for full information. Shoul= d be initiated and supervised by physicians with experience in the treatmen= t of epilepsy. Fintepla is prescribed and dispensed according to the Fintep= la controlled access programme. Dravet syndrome: Patients who are not takin= g stiripentol: Starting dose is 0.1 mg/kg twice daily (0.2 mg/kg/day). Afte= r 7 days, if tolerated, can increase dose to 0.2 mg/kg twice daily (0.4 mg/= kg/day). After an additional 7 days, if tolerated and further seizure reduc= tion required, can increase dose to a maximum of 0.35 mg/kg twice daily (0.= 7 mg/kg/day), which is the recommended maintenance dose. Patients requiring= more rapid titration may increase the dose every 4 days. Do not exceed max= imum daily dose of 26 mg (13 mg twice daily). Patients who are taking stiri= pentol: Starting dose is 0.1 mg/kg twice daily (0.2 mg/kg/day). After 7 day= s, if tolerated, can increase dose to 0.2 mg/kg twice daily (0.4 mg/kg/day)= , which is the recommended maintenance dose. Patients requiring more rapid = titration may increase the dose every 4 days. Do not exceed a total dose of= 17 mg (8.6 mg twice daily). Lennox-Gastaut syndrome: Starting dose is 0.1 = mg/kg twice daily (0.2 mg/kg/day). After 7 days, the dose should be increas= ed to 0.2 mg/kg twice daily (0.4 mg/kg/day), if tolerated. After an additio= nal 7 days, if tolerated, dose should be increased to 0.35 mg/kg twice dail= y (0.7 mg/kg/day), which is the recommended maintenance dose. Do not exceed= maximum daily dose of 26 mg (13 mg twice daily). Discontinuation: When dis= continuing treatment, decrease the dose gradually. As with all anti-epilept= ic medicines, avoid abrupt discontinuation when possible to minimize the ri= sk of increased seizure frequency and status epilepticus. A final echocardi= ogram should be conducted 3-6 months after the last dose of treatment with = fenfluramine. Renal impairment: Generally, no dose adjustment is recommende= d when administered to patients with mild to severe renal impairment, howev= er, a slower titration may be considered. If adverse reactions are reported= , a dose reduction may be needed. Has not been studied in patients with end= -stage renal disease. Not known if fenfluramine or its active metabolite, n= orfenfluramine, is dialyzable. Hepatic impairment: Hepatic impairment: Gene= rally, no dose adjustment is recommended when Fintepla is administered with= out concomitant stiripentol to patients with mild and moderate hepatic impa= irment (Child-Pugh Class A and B). In patients with severe hepatic impairme= nt (Child-Pugh C) not receiving concomitant stiripentol, the maximum dosage= is 0.2mg/kg twice daily, and the maximal total daily dose is 17 mg. There = are limited clinical data on the use of Fintepla with stiripentol in patien= ts with mild impaired hepatic function. A slower titration may be considere= d in patients with hepatic impairment and a dose reduction may be needed if= adverse reactions are reported. No clinical data is available on the use o= f Fintepla with stiripentol in moderate and severe hepatic impairment, ther= efore not recommended for use. Elderly: No data available. Paediatric popul= ation: Safety and efficacy in children below 2 years of age not yet establi= shed. No data available.=C2=A0 Contraindications: Hypersensitivity to active substance or any excipients. = Aortic or mitral valvular heart disease and pulmonary arterial hypertension= . Within 14 days of the administration of monoamine oxidase inhibitors due = to an increased risk of serotonin syndrome.=C2=A0 Warnings and Precautions: Aortic or mitral valvular heart disease and pulmo= nary arterial hypertension: Prior to starting treatment, patients must unde= rgo an echocardiogram to establish a baseline and exclude any pre-existing = valvular heart disease or pulmonary hypertension. Conduct echocardiogram mo= nitoring every 6 months for the first 2 years and annually thereafter. If a= n echocardiogram indicates pathological valvular changes, consider follow-u= p earlier to evaluate whether the abnormality is persistent. If pathologica= l abnormalities seen on echocardiogram, evaluate the benefit versus risk of= continuing fenfluramine treatment with the prescriber, caregiver and cardi= ologist. Once treatment is discontinued for any reasons, a final echocardio= gram should be conducted 3-6 months after the last dose of treatment with f= enfluramine. If echocardiogram findings suggestive of pulmonary arterial hy= pertension, perform a repeat echocardiogram as soon as possible and within = 3 months to confirm these findings. If echocardiogram finding is confirmed = suggestive of an increased probability of pulmonary arterial hypertension d= efined as intermediate probability, conduct a benefit-risk evaluation of co= ntinuation of Fintepla by the prescriber, carer and cardiologist. If echoca= rdiogram suggests a high probability, it is recommended fenfluramine treatm= ent should be stopped. Decreased appetite and weight loss: Fenfluramine can= cause decreased appetite and weight loss - an additive effect can occur in= combination with other anti-epileptic medicines such as stiripentol. Monit= or the patient=E2=80=99s weight. Undertake risk-benefit evaluation before s= tarting treatment if history of anorexia nervosa or bulimia nervosa. Fintep= la controlled access programme: A controlled access programme has been crea= ted to 1) prevent off-label use in weight management in obese patients and = 2) confirm that prescribing physicians have been informed of the need for p= eriodic cardiac monitoring in patients taking Fintepla. Somnolence: Fenflur= amine can cause somnolence which could be potentiated by other central nerv= ous system depressants. Suicidal behaviour and ideation: Suicidal behaviour= and ideation have been reported in patients treated with anti-epileptic me= dicines in several indications. Advise patients and caregivers to seek medi= cal advice should any signs of suicidal behaviour and ideation emerge. Sero= tonin syndrome: Serotonin syndrome, a potentially life-threatening conditio= n, may occur with fenfluramine treatment, particularly with concomitant use= of other serotonergic agents; with agents that impair metabolism of seroto= nin such as MAOIs; or with antipsychotics that may affect the serotonergic = neurotransmitter systems. Carefully observe the patient, particularly durin= g treatment initiation and dose increases. Increased seizure frequency: A c= linically relevant increase in seizure frequency may occur during treatment= , which may require adjustment in the dose of fenfluramine and/or concomita= nt anti-epileptic medicines, or discontinuation of fenfluramine, should the= benefit-risk be negative. Cyproheptadine: Cyproheptadine is a potent serot= onin receptor antagonist and may therefore decrease the efficacy of fenflur= amine. If cyproheptadine is added to treatment with fenfluramine, monitor p= atient for worsening of seizures. If fenfluramine treatment is initiated in= a patient taking cyproheptadine, fenfluramine=E2=80=99s efficacy may be re= duced. Glaucoma: Fenfluramine can cause mydriasis and can precipitate angle= closure glaucoma. Discontinue therapy in patients with acute decreases in = visual acuity. Consider discontinuation if ocular pain of unknown origin. E= ffect of CYP1A2 or CYP2B6 inducers: Co-administration with strong CYP1A2 in= ducers or CYP2B6 inducers will decrease fenfluramine plasma concentrations,= which may lower the efficacy of fenfluramine. If co-administration is cons= idered necessary, the patient should be monitored for reduced efficacy and = a dose increase of fenfluramine could be considered provided that it does n= ot exceed twice the maximum daily dose (52 mg/day). If a strong CYP1A2 or C= YP2B6 inducer is discontinued during maintenance treatment with fenfluramin= e, consider gradual reduction of the fenfluramine dosage to the dose admini= stered prior to initiating the inducer. Effect of CYP1A2 or CYP2D6 inhibito= rs: Initiation of concomitant treatment with a strong CYP1A2 or CYP2D6 inhi= bitor may result in higher exposure and, therefore, adverse events should b= e monitored, and a dose reduction may be needed in some patients. Excipient= s: Contains sodium ethyl para-hydroxybenzoate (E 215) and sodium methyl par= a-hydroxybenzoate (E 219) - may cause allergic reactions (possibly delayed)= . It also contains sulfur dioxide (E 220) which may rarely cause severe hyp= ersensitivity reactions and bronchospasm. Patients with rare glucose-galact= ose malabsorption should not take this medicine. The product contains less = than 1 mmol sodium (23 mg) per the maximum daily dose of 12 mL; essentially= =E2=80=98sodium-free=E2=80=99. Contains glucose - may be harmful to teeth.= Interactions: Pharmacodynamic interactions with other CNS depressants incr= ease the risk of aggravated central nervous system depression. An increase = in dose may be necessary when coadministered with rifampicin or a strong CY= P1A2 or CYP2B6 inducer. In in vitro studies co-administration with a strong= CYP1A2 or CYP2D6 inhibitor may result in higher exposure (see section 4.4 = of the SmPC). Co-administration with CYP2D6 substrates or MATE1 substrates = may increase their plasma concentrations. Co-administration with CYP2B6 or = CYP3A4 substrates may decrease their plasma concentrations. Pregnancy and l= actation: Limited data in pregnant women. As a precaution, avoid use of Fin= tepla in pregnancy. It is unknown whether fenfluramine/metabolites are excr= eted in human milk. Animal data have shown excretion of fenfluramine/metabo= lites in milk. A decision must be made whether to discontinue breast-feedin= g or to discontinue/abstain from Fintepla taking into account the benefit o= f breast-feeding for the child and the benefit of therapy for the woman. Dr= ive and use machines.: Fintepla has moderate influence on the ability to dr= ive/ use machines as it may cause somnolence and fatigue. Advise patients n= ot to drive or operate machinery until they have sufficient experience to g= auge whether it adversely affects their abilities.=C2=A0 Adverse effects: Dravet syndrome: Very common (=E2=89=A51/10): Upper respir= atory tract infection, decreased appetite, somnolence, diarrhoea, pyrexia, = fatigue, blood glucose decreased, echocardiogram abnormal (Consisted of tra= ce and mild mitral regurgitation, and trace aortic regurgitation, which are= considered physiologic). Common (=E2=89=A51/100 to <1/10): Bronchitis, abn= ormal behaviour, aggression, agitation, insomnia, mood swings, ataxia, hypo= tonia, lethargy, seizure, status epilepticus, tremor, constipation, salivar= y hypersecretion, weight decreased and blood prolactin increased. Not known= (cannot be estimated from the available data): Pulmonary arterial hyperten= sion. Lennox-Gastaut syndrome: Very common (=E2=89=A51/10): Upper respirato= ry tract infection, decreased appetite, somnolence, diarrhoea, vomiting, fa= tigue. Common (=E2=89=A51/100 to <1/10): Bronchitis, influenza, pneumonia, = aggression, seizure, status epilepticus, lethargy, tremor, constipation, sa= livary hypersecretion, blood prolactin increased, weight decreased, fall. R= efer to SmPC for other adverse reactions. Pharmaceutical Precautions: Use w= ithin 3 months of opening. Do not refrigerate or freeze. Package Quantities= and Marketing Authorisation Number: Fintepla is presented in a white bottl= e with oral syringes included which should be used to administer the prescr= ibed dose. Bottle sizes of 60 mL, 120 mL, 250mL and 360 mL. EU/1/20/1491/00= 1, EU/1/20/1491/002, EU/1/20/1491/003 and EU/1/20/1491/004. Legal Category:= POM. Marketing Authorisation Holder: UCB Pharma S.A. All=C3=A9e de la Rech= erche 60, B-1070 Bruxelles, Belgium. Date of revision: 27 March 2024. =E2=96=BCThis medicinal product is subject to additional monitoring. This w= ill allow quick identification of new safety information. Healthcare profes= sionals are asked to report any suspected adverse reactions. FINTEPLA^=C2=AE is a registered trademark of the UCB Group of Companies. Refer to the European Summary of Product Characteristics for further safety= information and full prescribing information.=C2=A0 https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0r= C2tJ60H3Fdk1VajTAIAj7NPJeYj-2Ba-2BL1r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQ= aFCaKaA-2FhhHiEtjJrI6ETeeE-2B8v74OWhjYCGt58GnH1fk5gg70icujQcJqxcsLpcg-3D-3D= pZbh_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TS= az3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33rPGQBEW= yWjOUwNPK4Z82f-2BDB6SHMwgWrKtDq4JCWyUopircJ6irEZvZRs-2FZ4Laff9bM-2BNFy2c1s9= Es-2B9tLpGKDIXZq1RR8qgwwVdHqy-2FLS4KVDmbduH9OYAwtJYFRooZK33UHb7ocf6XtzoW5T-= 2FGpGAfAMekRV-2FKSf8xol3-2Buqn9bGf5wG-2FF5Wbhw1s0o-2FayQlL4qKU0OkaU-2FRkAf-= 2FZPDypLJSVFFKKlwdX0tHnTVrQ-3D Forward looking statements=C2=A0 This press release may contain forward-looking statements including, withou= t limitation, 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=9Cestim= ates=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccont= inue=E2=80=9D and similar expressions. 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Important factors that could result in such differences include: change= s in general economic, business and competitive conditions, the inability t= o obtain necessary regulatory approvals or to obtain them on acceptable ter= ms or within expected timing, costs associated with research and developmen= t, changes in the prospects for products in the pipeline or under developme= nt by UCB, effects of future judicial decisions or governmental investigati= ons, safety, quality, data integrity or manufacturing issues; potential or = actual data security and data privacy breaches, or disruptions of our infor= mation technology systems, product liability claims, challenges to patent p= rotection for products or product candidates, competition from other produc= ts including biosimilars, changes in laws or regulations, exchange rate flu= ctuations, changes or uncertainties in tax laws or the administration of su= ch laws, and hiring and retention of its employees. 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UCB expressly disclaims any duty t= o update any information contained in this press release, either to confirm= the actual results or to report or reflect any change in its forward-looki= ng statements with regard thereto or any change in events, conditions or ci= rcumstances on which any such statement is based, unless such statement is = required 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. MHLW Notice 26 March 2024. https://u7061146.ct.sendgrid.net/ls/click?upn= =3Du001.gqh-2BaxUzlo7XKIuSly0rCyy0FBvi5xRQ58W-2BfSbWbcPb0nIRcgL2snYlfCmI8hQ= -2F9t-2Fco6Nw9VlS8vwQlN9E6jEVr0T1I49Yd-2B32jIoy3EQ-3Dd27W_2dCLUNbuBjhX746-2= FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3= MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33rPGQBEWyWjOUwNPK4Z82f-2BDB6SH= MwgWrKtDq4JCWyUopircJ6irEZvZRs-2FZ4Laff9bM-2BNFy2c1s9Es-2B9tLpGKDmqRDDK9pdw= mSpjtXkYWeg-2B87m2nyqI-2B5rOdcB7L4C8atN-2Bc-2BXRmc-2BrUJ9gdQaXwcuU7hbQLGW7j= kkcuiCWbE6vSKK2dWg-2FuWSrNwjubrlJj2PfNA5qGhZiOzmCm4p2arMQtYH-2FWT5PXADmrErm= rO0-3D Accessed March 2024. 2. Knupp K, Scheffer I, Ceulemans B, et al. Efficacy and safety of fenflura= mine for the treatment of seizures associated with Lennox-Gastaut syndrome.= A Randomized Clinical Trial. JAMA Neurol. 2022;79(6):554-564 3. Strzelczyk A, Schubert-Bast S. Expanding the Treatment Landscape for Len= nox-Gastaut Syndrome: Current and Future Strategies. CNS Drugs. 2021;35(1):= 61-83. 4. Specchio, N, Wirrell, EC, Scheffer, IE, Nabbout, R, Riney, K, Samia, P, = et al. International League Against Epilepsy classification and definition = of epilepsy syndromes with onset in childhood: Position paper by the ILAE T= ask Force on Nosology and Definitions. Epilepsia. 2022;63:1398-1442. 5. Reaven NL, Funk SE, Montouris GD, et al. Burden of illness in patients w= ith possible Lennox-Gastaut syndrome: a retrospective claims-based study. E= pilepsy Behav.2018;88:66-73. 6. Reyhani A, =C3=96zkara =C3=87. The unchanging face of Lennox-Gastaut syn= drome in adulthood. Epilepsy Res. 2021;172:106575. 7. Auvin S, Damera V, Martin M, et al. The impact of seizure frequency on q= uality of life in patients with Lennox-Gastaut syndrome or Dravet syndrome.= Epilepsy Behav. 2021;123:108239. 8. Jahngir MU, Ahmad MQ, Jahangir M. Lennox-Gastaut syndrome: in a nutshell= . Cureus. 2018;10(8):e3134. 9. Mastrangelo M. Lennox-Gastaut syndrome: a state of the art review. Neuro= pediatrics. 2017;48(3):143-51. 10. Fintepla^=C2=AE EU SmPC. https://u7061146.ct.sendgrid.net/ls/click?upn= =3Du001.gqh-2BaxUzlo7XKIuSly0rC2tJ60H3Fdk1VajTAIAj7NPJeYj-2Ba-2BL1r-2B0jLM-= 2FtfvSeD3KLQsazq58-2BxwfyV7LSQaFCaKaA-2FhhHiEtjJrI6ETeeE-2B8v74OWhjYCGt58Gn= H1T27RJn16IWmxyZWsDIvi2A-3D-3DVdRL_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPG= CjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33S= bkEZvEGLNn-2B6FohpNoV33rPGQBEWyWjOUwNPK4Z82f-2BDB6SHMwgWrKtDq4JCWyUopircJ6i= rEZvZRs-2FZ4Laff9bM-2BNFy2c1s9Es-2B9tLpGKBLBavSKvLloRO3S8nWEoeIReFTtw8hshua= YZiFWkw5VO8vY-2BSKMNEwK5-2FRuCFx9ld3Y8m1BbA7Fk2O-2BRFxz2hbFfOW-2FAUrMbwYOqK= HbcyZBgrqTM3Pwq-2FfWtxX6s5X50XTp-2FhV-2BiWS0w8asWLRoLWk-3D Accessed March 2= 023. GenericFile UCB PR Fintepla for LGS Japan Approval April 17 2024 ENG (https://u7061146.= ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rCyBv9bezcPT-2BuIt= TLKIHepafsoeIB9L1yKMHYtFqrtje6-2FBCAWm9uxnsx7S6a3s3RjMH3soqsT3trU6vN75-2B3P= E-3Do7hT_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2I= J0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33rPG= QBEWyWjOUwNPK4Z82f-2BDB6SHMwgWrKtDq4JCWyUopircJ6irEZvZRs-2FZ4Laff9bM-2BNFy2= c1s9Es-2B9tLpGKFepRVpouMeL3CmcxW0TeRktI3WFIt8gKYBafZ42zKzvJzWbqdHzAdeCztW0S= hPaFeUQFfwT07f9RjVErw8R1CvVSVKN1qTSN3QYJiYGa-2FA-2Beswk93jsbta4obrZQp2PoiI-= 2BlhIEUo9-2Bjv7wSeD6sus-3D ______________________ If you would rather not receive future communications from UCB SA, please g= o to https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIu= Sly0rC3nfmD42E6tJ6HwHGmqtXbhtXDlQ2cTEdRpWV-2BrYPIUN7QgPG-2FBTQhHgNVyPWqHaa8= p3tkzxjTeHB0c4i6dSWqzzKXU9z-2BiFlU6SvRpS27N85yQmJJ7oOeEI1B5cx29HlEQjLC3ll2X= l9M5qwZCfKek-3DAB9K_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2= nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6F= ohpNoV33rPGQBEWyWjOUwNPK4Z82f-2BDB6SHMwgWrKtDq4JCWyUopircJ6irEZvZRs-2FZ4Laf= f9bM-2BNFy2c1s9Es-2B9tLpGKGCjF2SmkgTP2ccrGGipIQWgdI1MnJrAk-2FIUD34k6HP7F1l1= YI6gLrLDPGwf1ed4bUdEuegVYErBVyJTUCEDjK3IV158kYdhQ1U6TljZrY3Wy2UbVG-2BgozZOV= lVKaMXmcSxlsTGRoi9uIocZjDyUgAY-3D UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . 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