GlaxoSmithKline and Valeant granted EU approval for epilepsy drug

GlaxoSmithKline and Valeant Pharmaceuticals have received European regulatory approval for Trobalt (retigabine), a new epilepsy treatment.

The European Commission has given its authorisation for the drug to be marketed as an add-on therapy for partial onset seizures among epilepsy patients aged 18 and above.

Approval has been granted based on positive data from pivotal phase III trials, during which the treatment was shown to deliver a reduction in seizure frequency when compared to placebo.

This represents the first licence to be granted to the new drug, which has been developed as part of a collaboration between GlaxoSmithKline and Valeant agreed in 2008.

Dr Tony Hoos, senior vice-president for European medical affairs at GlaxoSmithKline, said: "The European authorisation of retigabine is very welcome as it will provide neurologists within Europe with a new therapeutic option for the management of appropriate patients with uncontrolled partial onset seizures."

Earlier this month, GlaxoSmithKline was granted approval from the Scottish Medicines Consortium for its kidney cancer treatment Votrient to be made available to NHS patients in Scotland.