UCB announces positive CHMP opinion on epilepsy drug

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has delivered a positive recommendation to the European Commission to allow UCB market authorisation for its Keppra (levetiracetam) epilepsy therapy.

Keppra is being authorised as an adjunctive treatment for patients with idiopathic generalised epilepsy suffering from primary generalised tonic-clonic seizures.

In recent clinical trials, patients administered with Keppra exhibited greater freedom from seizures and a reduction of seizure frequency at greater rates than those administered with a placebo, with a predictable toleration of the compound.

Troy Cox, president of CNS operations at UCB, said: “The CHMP recommendation represents another important milestone in the development program for Keppra. In the clinical trial supporting this application, Keppra was well tolerated and significantly reduced tonic-clonic seizures.”

He added that the company now hopes to make the drug more widely available to patients with generalised seizures.

Keppra is currently licensed in the EU as a monotherapy for partial onset seizures in newly diagnosed cases of epilepsy and as an adjunctive therapy for partial onset seizures and myoclonic seizures.

In February, UCB announced that the CHMP had delivered a positive marketing authorisation recommendation for the use of a concentrate of Keppra for intravenous administration for the treatment of partial onset seizures with or without secondary generalisation.