UCB today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended that the European Commission grant marketing authorisation for Neupro (rotigotine transdermal patch) in the symptomatic treatment of moderate-to-severe idiopathic Restless Legs Syndrome (RLS) in adults.
The CHMP decision is based on data from two well-controlled clinical trials that evaluated the efficacy and safety of Neupro over a six month period in almost 1,000 patients with RLS.
In these trials, Neupro showed significant and clinically relevant improvements in RLS symptoms compared to placebo and was generally well tolerated.
“The CHMP recommendation is encouraging news and we are hopeful that the European Commission will act favourably on the marketing authorisation for Restless Legs Syndrome,” said Troy Cox, President CNS Operations, UCB.
“We will be filing a Restless Legs Syndrome manufacturing variation with the EMEA. We are looking forward to making Neupro available as a new therapeutic option to people living with this chronic neurological disorder.”
Restless Legs Syndrome affects between three and 10% of the population, causing unpleasant sensations such as tingling, burning, tugging, gnawing and pulling in the legs. Symptoms frequently occur during periods of rest and inactivity such as during long flights and car trips, or at night.