UCB Pharma has successfully filed its investigational antiepileptic brivaracetam with regulators on both sides of the Atlantic.
Both the US Food and Drug Administration and the European Medicines Agency have agreed to review brivaracetam as adjunctive therapy for the treatment of partial-onset seizures in patients from 16 years of age with epilepsy.
The filings are backed by data from a comprehensive clinical development program involving over 3,000 people, and six follow-up studies assessing the drug’s long-term safety and efficacy are ongoing.
UCB has high hopes for its Keppra (levetiracetam) follow-up, particularly as it claims brivaracetam has been shown to have a 10-fold higher affinity for synaptic vesicle protein 2A than the older drug, which means that it is more potent than the latter in controlling seizure activity.
Epilepsy affects around 65 million people worldwide.