FDA Approves Keppra Intravenous Formulation

Brussels, Belgium - Today UCB announced that the U.S. Food and Drug Administration (FDA) has approved Keppra (levetiracetam) injection 500mg/5mL (100mg/mL) for use as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. Keppra injection is an alternative for patients when oral administration is temporarily not feasible; it must be diluted prior to use and administered as a 15-minute intravenous infusion.

"The addition of new intravenous formulations extend the treatment spectrum for patients with epilepsy allowing therapy to be individualized to particular clinical situations," said Orrin Devinsky, Professor of Neurology, Neurosurgery and Psychiatry, Comprehensive Epilepsy Center, New York University, U.S. He continued, "The FDA approval of the intravenous formulation for Keppra provides a welcome new option for U.S. physicians and patients."

Troy Cox, President CNS Operations, UCB said, "This U.S. approval closely follows the European approval of the IV formulation for Keppra earlier this year. Keppra is now the only newer anti-epileptic drug available in the U.S. and Europe with both oral and intravenous formulations."

In March 2006 the European Commission approved the use of Keppra 100 mg/mL concentrate for solution for intravenous infusion for use as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalization in adults and children four years of age and older with epilepsy.

SOURCE: UCB