UCB receives European OK for use of Keppra as monotherapy for epilepsy

By E. Janene Geiss

Philadelphia, July 3 - UCB announced Monday that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion to approve marketing authorization of Keppra (levetiracetam) as monotherapy in the treatment of partial onset seizures with or without secondary generalization in patients from 16 years of age with newly diagnosed epilepsy.

UCB said it has undertaken a comprehensive clinical trial program for Keppra and this approval follows 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, according to a company news release.

The submission was based on a well-controlled phase 3 non-inferiority monotherapy trial comparing Keppra with optimized use of controlled-release carbamazepine.

Data from this trial demonstrated that Keppra was non-inferior to controlled-release carbamazepine when used as monotherapy in the first-line treatment of adult patients with partial or generalized tonic-clonic seizures, and showed a more favorable tolerability profile, officials said.

In this trial Keppra demonstrated six- and 12-month seizure freedom rates of 73% and 56.6%, respectively when used as monotherapy in newly diagnosed patients, officials said.

In Europe, Keppra is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalization in adults and children from 4 years of age with epilepsy and as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.

In the United States, Keppra is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children four years of age and older with epilepsy.

UCB is a Brussels, Belgium, biopharmaceutical company focused on central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology.

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