UCB files brivaracetam at FDA and EU for treatment of Partial-Onset Seizures in patients with Epilepsy

UCB has announced regulatory milestones in the US and the EU for its investigational antiepileptic drug brivaracetam ( proposed trade name Rikelta). In the US, the FDA has accepted for review the New Drug Application (NDA) for brivaracetam as adjunctive therapy for the treatment of Partial-Onset Seizures in patients from 16 years of age with Epilepsy, and in the EU, the European Medicines Agency has validated for review the Marketing Authorization Application (MAA) for brivaracetam in the same proposed indication. Acceptance for review indicates that the FDA and EMA have found the Company's submissions to be sufficiently complete to proceed.

The US NDA and the EU MAA are supported by data from a comprehensive clinical development program including three Phase III studies which evaluated the efficacy and safety of adjunctive brivaracetam (5 mg-200 mg/day dose range) in patients with uncontrolled partial-onset seizures. A supportive fourth Phase III study evaluated the safety and tolerability of adjunctive brivaracetam given at individualized tailored doses between 20 and 150 mg/day in adult patients with Partial-Onset Seizures.