UCB boasts of new regulatory milestone for Keppra

The panel’s positive opinion concerns the use of Keppra (levetiracetam) as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.

The submission is based on a well-controlled phase III non-inferiority monotherapy trial comparing Keppra with optimized use of controlled-release (CR) carbamazepine. Data from this trial demonstrated that Keppra was non-inferior to CR-carbamazepine when used as monotherapy in the first-line treatment of adult patients with partial or generalized tonic-clonic seizures, and showed a more favorable tolerability profile.

In this trial Keppra demonstrated six- and 12-month seizure freedom rates of 73% and 56.6%, respectively, when used as monotherapy in newly diagnosed patients.

“UCB has undertaken a comprehensive clinical trial program for Keppra and this positive news follows closely behind two recent European approvals for Keppra – a new intravenous formulation, and a new indication as add-on therapy in the treatment of myoclonic seizures in juvenile myoclonic epilepsy,” said Dr Peter Verdru, vice president of clinical research and head of neurology/psychiatry clinical development at UCB. “We look forward to receiving the final determination of the European Commission and to making Keppra available as a first-line treatment to epilepsy patients.”

In Europe, Keppra is currently indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalization in adults and children from four years of age with epilepsy and as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.