UCB Pharma seeks new indication for epilepsy treatment

Keppra (levetiracetam) is currently approved for adjunctive therapy in the treatment of partial onset seizures in adults and children aged four years of age and older with epilepsy. The new, sought, indication is in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy (JME), a common type of epilepsy that requires life-long treatment with anti-epileptic drugs (AEDs).

While seizures associated with JME can usually be controlled with medication, a large number of patients with JME either don’t respond to or cannot tolerate standard first-line treatments. In addition, many JME patients are treated with inappropriate AEDs, which are either ineffective against myoclonic seizures or associated with unacceptable side effects.

The application for a new indication for Keppra is based on the first double-blind, placebo-controlled study evaluating the efficacy and safety of an anti-epileptic drug in 120 patients with idiopathic generalized epilepsy (IGE) who experience myoclonic seizures.

“A surprising number of patients (up to 45%) do not respond to current first line or newer therapies. This pivotal study shows that Keppra may be an effective treatment option for these patients that are difficult to treat,” said study investigator Gregory Krauss, associate professor of neurology at Johns Hopkins Medical School.

The study showed that Keppra 3000mg/day for 12 weeks reduced the rate of myoclonic seizure days by at least half in 58% of treated patients compared to 23.3% of placebo.