On September 15, UCB announced that its latest anti-epileptic drug (AED), Briviact (brivaracetam), has been approved as a monotherapy for partial onset seizures in patients aged 16 years and older who suffer from epilepsy, expanding its potential patient population.
Briviact’s active ingredient, brivaracetam, is an analog of UCB’s blockbuster Keppra (levetiracetam). Briviact was originally approved as an adjunctive therapy for partial onset seizures in epilepsy patients aged 16 years and older in January 2016. The drug is part of the ‘racetam’ class of medicines, which have a high, selective affinity for synaptic vesicle protein 2A (SV2A), which is thought to be responsible for the drug’s anticonvulsant effect.
GlobalData anticipates that UCB will continue to try and expand Briviact’s market penetration, with another supplementary new drug application (sNDA) likely for approval in pediatric patients. If the drug is approved for pediatric patients, the exclusivity period of the drug will be extended by a further six months, which will delay generic entry. Furthermore, in order to maintain its hold on the market, UCB will aim to launch Briviact as both a monotherapy and adjunctive therapy in Japan for epilepsy patients with partial onset seizures. In GlobalData’s soon-to-be published report, PharmaPoint: Epilepsy – Opportunity Analysis and Forecasts to 2026, Briviact has been forecast to launch in all 7MM and is anticipated to reach peak sales of $353M in 2025, making it one of the highest selling AEDs on the market.
UCB has experienced declining sales for Keppra due to patent expiry. However, these label expansions for Briviact, along with the company’s strong epilepsy pipeline, will enable UCB to maintain its position as the market leader in the epilepsy market for the foreseeable future.