UCB has announced regulatory milestones in the US and the EU for its investigational antiepileptic drug brivaracetam. In the US, the Food and Drug Administration (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.
“Today is a major milestone for brivaracetam and an exciting day for everyone at UCB who is committed to its development. It is also an important time for the clinicians and patients whose involvement in brivaracetam clinical trials has been so important in helping us to address the need for new treatment options for adult patients who do not achieve partial-onset seizure control with current antiepileptic drugs. We look forward to working closely with the FDA and EMA through the review process.” said Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President UCB.
The US NDA and the EU MAA are supported by data from a comprehensive clinical development program including three Phase 3 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 3 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.
Overall, the brivaracetam clinical development program has involved over 3000 people and over 8 years of experience for some patients. There are six on-going studies of brivaracetam.
These are predominantly open-label, follow-up studies to assess long-term safety and efficacy of brivaracetam. Discovered and developed by UCB, brivaracetam is a selective synaptic vesicle protein 2A ligand.