UCB Pharma’s anti-epileptic, Keppra (levetiracetam), has won US Food and Drug Administration approval as add-on therapy in the treatment of partial-onset seizures in children four years of age and older with epilepsy.
This new paediatric indication was assessed under priority review, which is awarded to products that address unmet medical needs and represent a significant improvement to therapies already available [[17/02/05f]]. It sets a six-month review target.
The new approval was based on the results of a clinical trial in 198 children aged four to 16 years suffering from epilepsy. Those taking Keppra had a significantly larger reduction (27%) in weekly seizure frequency over placebo, on average. In addition, some 45% of patients responded to treatment (achieving a 50% or greater reduction in seizures), versus 20% for placebo.
Keppra was approved in the US back in 1999 as adjunctive therapy for adults with partial onset seizures and UCB claims it is the most prescribed second-generation anti-epileptic drugs used in epilepsy in the US.