UCB Pharma files supplemental new drug application for Keppra

By Jennifer Chiou

New York, Oct. 27 - UCB Pharma, Inc. said it filed a supplemental new drug application with the U.S. Food and Drug Administration for the use of Keppra levetiracetam as adjunctive therapy for myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy (JME).

JME is a common type of epilepsy that requires lifelong treatment with antiepileptic drugs.

Keppra is already approved for adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

The application is based on the first double-blind, randomized, placebo-controlled study for the efficacy and safety of the drug in 120 patients with idiopathic generalized epilepsy who experience myoclonic seizures, UCB said.

The company noted the study showed that Keppra at 3,000 mg a day for 12 weeks reduced the rate of myoclonic seizure days by at least half in 58% of treated patients compared to 23.3% with a placebo.

"No other anti-epileptic drug has undergone such rigorous testing to determine its safety and efficacy in patients suffering from idiopathic generalized epilepsy with myoclonic seizures," Peter Verdru, vice president of clinical research ad head of neurology/psychiatry clinical development, said in a news release.

Based in Smyrna, Ga., UCB researches and develops biopharmaceutical products for central nervous system disorders, allergy and respiratory diseases, immune and inflammatory disorders and oncology. Parent UCB SA has headquarters in Brussels, Belgium.

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