UCB's Keppra receives two regulatory approvals for use in epilepsy

By Lisa Kerner

Erie, Pa. April 26 - The European Commission has approved the use of UCB's Keppra (levetiracetam) 100 mg/mL concentrate for intravenous infusion in the European Union.

Specifically, Keppra is approved for use as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalization in adults and children four years and older with epilepsy.

UCB said the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the approval of Keppra as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.

The committee's opinion is now forwarded to the European Commission for review and final decision, which is expected within 90 days, according to a company news release.

UCB's European Medicines Agency application is based on a phase 3, double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of Keppra as adjunctive therapy in the treatment of myoclonic seizures in patients with idiopathic generalized epilepsy.

The company presented the results at the 26th International Epilepsy Congress in Paris in August 2005.

"Keppra is now the first and only newer anti-epileptic drug with both oral and intravenous formulations and we are pleased to provide European physicians and hospitals with an alternative for patients when oral administration is not feasible," president, CNS operations, Troy Cox stated in the release.

Based in Brussels, Belgium, UCB develops pharmaceutical and biotechnology products for central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology

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