Germany’s Schwarz Pharma moved a step closer to launching its patch-delivered treatment for early-stage Parkinson’s disease in the USA, although there will be a delay of a few months while it responds to a request for more information from the Food and Drug Administration.
Schwarz said the FDA had sent it an approvable letter for Neupro (rotigotine) asking for more data, but confirmed that the request could be met via additional analyses from the existing database. The company said it would respond to the letter within six months.
Neupro was cleared for marketing by the European Medicines Agency last month, and is due to be launched in its first EU markets in the next few weeks.
Schwarz said the patch administration of rotigotine offers the convenience of once daily-dosing, as well as a simple titration scheme for doctors and patients.
Schwarz is expecting peak sales of around 350 million euros ($418m) from the product in Parkinson’s disease, with an additional 300 million euros possible if the company can win approval of the product in a second indication, the treatment of restless legs syndrome. Results of Phase III trials in RLS are due early next year.