UCB is planning to seek approval for its epilepsy drug Vimpat as a monotherapy in Europe during the first six months of next year, having bagged Phase III data supporting its use in the setting.
The Belgian drugmaker has released top-line data from the trial showing non-inferiority of Vimpat (lacosamide) to carbamazepine-CR as monotherapy for newly/recently diagnosed adult patients with partial-onset seizures.
In the study, 90% of patients given the drug remained seizure free for six consecutive months of treatment, meeting its primary endpoint.
Vimpat was first launched in the European Union in September 2008 as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalisation in adults and adolescents (16-18 years) with epilepsy.
Approval as a monotherapy could significantly expand its scope, given that new patients can be initiated on the treatment and those already on an antiepileptic can be switched over to it.
The US Food and Drug Administration approved Vimpat monotherapy in Septmember last year.