UCB has received a Complete Response Letter from the US Food and Drug Administration (FDA) for its transdermal patch, Neupro (rotigotine transdermal system) to treat the signs and symptoms of advanced Parkinson's disease, and as a treatment for the signs and symptoms of moderate to severe primary Restless Legs Syndrome (RLS).
The FDA concluded that there was substantial evidence of effectiveness of Neupro in patients with advanced Parkinson's disease and in patients with RLS. However, UCB needs to first resolve the issue of crystal formation in the patches. UCB will discuss the contents of the Complete Response Letter and the next steps with the FDA.
The FDA accepted for filing the supplemental New Drug Applications (sNDAs) for the two indications in December 2007. At that time, Neupro was available in the US for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease and had been commercially available since July 2007. The company recalled Neupro from the US market in April 2008 after ongoing monitoring revealed that specific batches of Neupro had deviated from their approved specification.
In Europe, a complete cold-chain storage and distribution system, successfully implemented by September 2008, has helped to control the crystal formation issue and allowed existing patients to continue their therapy. Pending European regulatory authority decision, UCB aims to make Neupro available again to all patients suffering from Parkinson's disease in Europe, and to launch the Restless Legs Syndrome indication in Europe, during the first half of 2009.