UCB receives approval for Neupro

UCB has announced that Neupro (rotigotine) has been granted marketing authorisation for the treatment of moderate-to-severe Restless Leg Syndrome (RLS).

The European Medicines Agency (EMEA) accepted the filing for the patch which is designed to provide continuous drug delivery over a 24 hour period.

Troy Cox, president of Central Nervous System Operations at UCB, expressed his delight following the EMEA decision.

“This new filing for Neupro reflects UCB’s commitment to finding innovative medicines for conditions where there is a continuing need for alternative treatment.”

The marketing authorisation was based on the results of two studies evaluating the efficacy and safety of Neupro in over 1,000 patients over six months.

Neupro was shown to bring about significant reductions in RLS symptoms compared to a placebo and was generally well-tolerated.

The efficacy of rotigotine was assessed using the International Restless Legs Severity Scale, which evaluates the severity and frequency of RLS symptoms.

Neupro is already approved in Europe and the US for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s Disease as monotherapy.

Also this week, UCB announced positive phase III clinical trial results for Keppra XR (levetiracetam), its extended release tablets for the treatment of epilepsy.