UCB has got another green light from the European Commission to extend the approved uses of its Keppra epilepsy drug, this time to use the agent as adjunctive therapy in the treatment of adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.
Keppra (levetiracetam) is the first and only new-generation anti-epileptic drug approved in Europe for the treatment of myoclonic seizures in JME, according to the Belgian company. UCB also won approval last month for an intravenous formulation of the drug, extending the use of Keppra into emergency seizure setting where oral treatment is not an option.
JME is a common epilepsy syndrome that usually starts between the ages of 12 and 18 and accounts for about 10% of all cases of epilepsy. It is characterised by myoclonic jerks that occur in 100% of cases, with many patients also experiencing generalised tonic-clonic and absence seizures.
Keppra is one of UCB's star products, with sales growth in 2005 of 34%, reaching 560 million euros ($694m), and the new indication is expected to add to the product’s momentum in 2006.
Dr Soheyl Noachtar of the University of Munich, Germany, said there is a need in JME for drugs that are well-tolerated and do not aggravate seizures. In trials, he added 22% of Keppra patients achieved complete seizure freedom throughout the 12-week evaluation period compared with only 2% of placebo patients.
“With seizure freedom being the ultimate goal of epilepsy management Keppra may be a valuable addition to the clinician's armamentarium."
The JME indication and the new intravenous formulation of Keppra are still under regulatory review in the USA.