UCB announced that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending that the European Commission lifts the treatment restrictions for Neupro (rotigotine transdermal patch) in Europe.
"The positive opinion of the EMEA's CHMP is an important step towards making Neupro available to all patients with Parkinson's disease and to patients with Restless Legs Syndrome" said Troy Cox, senior vice president CNS Operations, UCB. "UCB is proud of its record of providing innovative treatment solutions for conditions that have a real unmet need. With Neupro we have a 24 hour, continuous drug delivery treatment that offers patients improvements in their symptoms and benefits to their everyday lives."
In June 2008, Neupro supply in Europe was limited to patients already established on the drug. UCB has fully implemented a cold-chain storage and distribution system and all stocks of Neupro (2 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h) have been replaced with product that is refrigerated from manufacturer to patient. Pending final approval of the European Commission, Neupro will be available to all patients with Parkinson's disease in Europe.
In August 2008, the European Commission approved Neupro for the symptomatic treatment of idiopathic moderate to severe Restless Legs Syndrome (RLS) in adults.