UCB submits brivaracetam for US and EU approval

UCB has announced the successful submission of brivaracetam, an investigational antiepileptic drug, for the approval of regulators on both sides of the Atlantic.

The US Food and Drug Administration and the European Medicines Agency have agreed to review brivaracetam as an adjunctive therapy for the treatment of partial-onset seizures in patients aged 16 and older.

This follows an eight-year clinical development programme comprising four Phase III studies, the most recent of which demonstrated the safety and tolerability of the drug at doses of between 20 and 150 mg per day in adults.

Commenting on the filing, UCB executive vice president and chief medical officer Dr Iris Loew-Friedrich said: "Today is a major milestone for brivaracetam and an exciting day for everyone at UCB who is committed to its development."

In addition to the company's Phase III trials, there are six ongoing studies of the drug that predominantly assess the long-term safety and efficacy of the treatment pathway.