Allergan receives regulatory backing for new EU Botox approval

Allergan has achieved an important milestone in its efforts to secure European regulatory approval for Botox as a treatment for focal spasticity of the ankle in adult post-stroke patients.

The Irish Medicines Board, which is serving as a reference member state in a European mutual recognition procedure (MRP), has issued a positive opinion on the approval of the botulinum toxin therapy in this indication.

It paves the way for the company to secure national licences in the 14 European countries involved in the MRP. The positive opinion was granted following a review of phase III trial data showing Botox's safety and efficacy for this purpose.

Allergan's drug can significantly improve muscle tone in stroke survivors with lower limb spasticity, thereby helping them to regain and retain mobility and other physical functions.

Paul Navarre, president of Allergan in Europe, the Middle East and Africa, said: "This decision underscores Allergan's longstanding commitment to innovation in botulinum toxin science and our significant research and development investments."

This comes after the UK's Medicines and Healthcare Products Regulatory Agency approved the drug in the same indication earlier this year. To date, Botox has been approved in 12 different indications in Britain.