UCB Pharma submitted the pediatric supplemental new drug application (sNDA) for Keppra on December 20, requesting approval of Keppra (levetiracetam) for the adjunctive treatment of partial seizures in children down to four years of age.
Keppra was first marketed in 2000 and is now the most prescribed second generation anti-epilepsy drug (AED) for adults with partial onset seizures in the US.
Under a priority review, the FDA sets a six-month target for deciding whether to approve a new drug application, instead of the standard target of ten months after the date the application is filed. A priority designation is intended for products that address unmet medical needs and, if approved, would be a significant improvement on products already on the market.
The application is based on recent pivotal trial results in 198 patients showing excellent efficacy and safety in children aged four to 16 years with refractory epilepsy. Results showed that 7% of the children who took Keppra became seizure free during the 14-week treatment period, compared with 1% of those taking placebo.