UCB gets positive opinion for Keppra epilepsy drug

UCB has announced it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) to market Keppra as a monotherapy for the treatment of partial onset seizures with or without secondary generalisation in patients diagnosed with epilepsy.

The CHMP will recommend Keppra to the European Medicines Agency to formally approve the drug for use in epilepsy patients aged 16 and above after studying the results of a phase III trial.

The trial indicated Keppra was not inferior to controlled-release carbamazepine in patients with partial or generalised tonic-clonic seizures and better tolerated. Keppra demonstrated 73 per cent seizure freedom, in comparison to 56.6 per cent of controlled-release carbamazepine.

Peter Verdru, vice-president of clinical research and head of neurology and psychiatry clinical development stated: “This current filing highlights our commitment to patients with newly diagnosed epilepsy.”

“UCB has undertaken a comprehensive clinical trial program for Keppra and this positive news follows closely behind two recent European approvals for Keppra – a new intravenous formulation, and a new indication as add-on therapy in the treatment of myoclonic seizures in juvenile myoclonic epilepsy,” he added.

Dr Verdru concluded: “We look forward to receiving the final determination of the European Commission and to making Keppra available as a first-line treatment to epilepsy patients.”

In related news, UCB spokesman Jean-Christophe Donck told Reuters Health yesterday that the company was interested in taking over “part or all” of Eli Lilly’s Belgian research facilities. Lilly said last week that it intends to close some of its European sites.

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