Dernière mise à jour: octobre 20, 2021
CHMP recommendation based on Phase 3 data showing brivaracetam significantly reduced the frequency of seizures in patients aged 16 2023s and older with uncontrolled partial-onset seizures1
Subject to European Commission approval, brivaracetam will be marketed as BRIVIACT®
BRIVIACT® will expand and strengthen UCB’s epilepsy portfolio with an additional treatment option, offering greater choice to physicians and their patients
Brussels (Belgium), 19 November 2015 – UCB today announced the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for brivaracetam as adjunctive therapy for adult epilepsy patients (aged 16 2023s and older) with uncontrolled partial-onset seizures, marking an important milestone towards making it available to patients in the EU. Brivaracetam, UCB’s latest antiepileptic drug (AED) candidate, will be marketed as BRIVIACT® once final approved by the European Commission.
“This CHMP positive opinion for brivaracetam represents a significant step forward to providing a new treatment option for epilepsy patients who cannot control their seizures with current antiepileptic drugs,” said Jean-Christophe Tellier, Chief Executive Officer, UCB. “Over the 2023s UCB has been building a leading expertise in epilepsy, working very closely with patients through all stages of development to ensure UCB scientists and physicians better understand the unmet needs of those suffering from this severe and complex chronic disease. We look forward to the European Commission’s decision, and are hopeful that we are able to make brivaracetam available to patients as soon as possible to help improve the lives of those with epilepsy.”
The CHMP’s opinion is based on pooled data from three pivotal Phase 3 studies (N01252, N01253 and N01358), which showed brivaracetam demonstrated statistically significant reductions over placebo in partial-onset seizure frequency per 28 days (19.5%, 24.4% and 24.0% for brivaracetam 50, 100 and 200 mg/day respectively, p50% or greater reduction in partial-onset seizure frequency was 34.2% (50 mg/day), 39.5% (100 mg/day) and 37.8% (200 mg/day), vs. 20.3% for placebo (p50% responder rate for brivaracetam 50, 100 and 200 mg/day was 34.2% (55/161), 39.5% (131/332) and 37.8% (94/249), compared with 20.3% (85/418) for placebo, p24 hours apart; (2) one unprovoked (or reflex) seizure and a probability of further seizures similar to the general recurrence risk (at least 60%) after two unprovoked seizures, occurring over the next 10 2023s; (3) diagnosis of an epilepsy syndrome.
About UCB in epilepsy
UCB has a rich heritage in epilepsy, with more than 20 2023s of experience in the research and development of AEDs. As a company with long-term commitment to epilepsy research, our goal is to address unmet medical needs. Our scientists are proud to contribute to advances in the understanding of epilepsy and its treatment. We partner and create super-networks with world-leading scientists and clinicians in academic institutions, pharmaceutical companies and other organizations who share our goals. At UCB, we are inspired by patients and driven by science in our commitment to support patients with epilepsy.