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 restless legs syndrome (RLS). In these trials, Neupro showed significant and clinically relevant improvements in RLS symptoms compared to placebo and was generally well tolerated.
Troy Cox, president CNS operations, UCB, said: “We will be filing a restless legs syndrome manufacturing variation with the European Medicines Agency . We are looking forward to making Neupro available as a new therapeutic option to people living with this chronic neurological disorder.”