Belgium’s UCB has received a boost with the news that the firm’s epilepsy drug Vimpat has been given the green light by European regulators.

The decision to approve Vimpat (lacosamide) comes after the European Medicines Agency received a recommendation from its Committee for Medicinal Products for Human Use in June. The oral drug, which is also available as an infusion, has been approved as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older.

The European thumbs-up is based on data from three multicentre, clinical trials involving over 1,300 partial-onset seizure patients. When added to a wide range of first and second generation antiepileptic drugs, pooled analysis showed that treatment with Vimpat 200 mg/day and 400 mg/day reduced seizures by half in 34% and 40% of patients, respectively, compared with 23% in the placebo group. The therapy was generally well tolerated.

UCB said that Vimpat will be launched shortly in the UK and Germany, and the drug is seen as a vital element in plugging the gap in sales facing UCB from the loss of patent protection on the allergy drug Zyrtec (cetirizine) last year and the antiepileptic Keppra (levetiracetam) next year.

The approval is particularly welcome seeing as the US Food and Drug Administration turned down its New Drug Application for Vimpat at the end of July as a treatment for diabetic neuropathic pain in adults. The drug is currently being reviewed by the EMEA for that indication and UCB is also considering whether to file Vimpat as a potential treatment for fibromyalgia.