Belgium’s UCB has received the nod from the European Commission for an intravenous formulation of its epilepsy drug Keppra, making it the only recently-introduced anticonvulsant medication to be approved for both oral and injectable use.
Keppra (levetiracetam) is already approved in tablet and oral solution formulations, but the intravenous version will extend use of the product into emergency seizure situations, where oral treatment is not an option. In the USA, the Food and Drug Administration issued an ‘approvable’ letter for the intravenous version in February, but UCB has said it expects final queries relating to labelling and manufacturing to be resolved swiftly.
The drug is currently approved for use as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults and children aged over four. But UCB also reported today Europe’s Committee for Medicinal Products for Human Use has recommended approval of Keppra as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (JME).
Keppra is one of UCB’s star products, with sales growth in 2005 of 34% to reach 560 million euros ($694m).