Belgian biopharmaceutical company UCB has reported that its top-selling drug, the epilepsy treatment Keppra (levetiracetam) is as effective as standard therapy as a first-line monotherapy for epileptics with partial or generalised tonic-clonic seizures.The company said it plans to file the new data with the European Medicines Agency later this year, with a view to getting approval for Keppra as a monotherapy in newly diagnosed patients. At present the drug is approved for use only as an adjunctive therapy, ie. in combination with other epilepsy drugs.
The Phase III results indicate that Keppra was as effective as sustained-release carbamazepine - the most widely prescribed drug for this type of epilepsy - in keeping patients seizure-free. Approximately 73% of patients in both treatment groups were seizure-free at six months, but Keppra had a more favourable tolerability profile, according to UCB.
This profile has already helped Keppra to become the most prescribed second-generation anti-epilepsy drug in the USA for partial-onset seizures and its sales have grown solidly since it was launched in 2000. In the first six months of 2005, the drug had sales of 258 million euros, up 34% year-on-year, helped by approval in the USA for use alongside other anti-epileptics in children aged four years and over [[27/06/05c]]. This indication is still under review in Europe.