UCB epilepsy drug gets new EC approval

UCB has announced that it has gained approval from the European Commission (EC) for the use of Keppra (levetiracetam) as an adjunctive therapy to treat primary generalised tonic-clonic (PGTC) seizures in patients aged over 12 suffering from idiopathic generalised epilepsy (IGE).

Keppra is currently indicated in Europe as a monotherapy treatment for partial onset seizures in patients over 16 with newly diagnosed epilepsy and as an adjunctive therapy for partial onset seizures in patients over four and those with myoclonic seizures.

Professor Emilio Perucca, of the University of Pavia, said: “PGTC seizures are the most serious seizure type within the generalised epilepsies.

“In the well-controlled trial supporting this indication, relatively high PGTC seizure freedom rates were observed with Keppra in previously drug refractory patients.”

He added that this new indication adds to the scope of efficacy of the compound as a therapy for partial and generalised seizures.

UCB launched Keppra in 2000 and has since focused its clinical development on increasing the seizure types for which it is indicated to treat a broader range of epilepsy patients.

In August 2006, UCB announced that the EC has approved Keppra as a monotherapy to treat partial onset seizures in patients with newly diagnosed epilepsy, with or without secondary generalisation, following a number of other new indications the compound received that year.