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FDA recommends reformulation of Neupro in the U.S.
In Europe and other countries, Neupro is not impacted by this recommendation.
UCB has already made progress in reformulation and remains committed to bringing Neupro to U.S. patients suffering from Parkinson’s disease and Restless Leg Syndrome.
UCB announced today that the U.S. Food and Drug Administration (FDA) has provided a complete response letter recommending reformulation of Neupro (Rotigotine Transdermal System) before making it available in the U.S. market for the treatment of Parkinson’s disease (PD) and restless legs syndrome (RLS). FDA’s response is to an NDA Supplement that UCB submitted in June 2009, with a proposal for new refrigerated storage conditions to alleviate crystallization on the patches.
“FDA agrees that the proposed new refrigeration conditions significantly inhibit the degree of crystallization on the patches, but has recommended that the definitive resolution of the crystallization is to reformulate the drug product,” said Prof. Dr. Iris Loew-Friedrich, Executive Vice President and Chief Medical Officer of UCB. “This FDA decision does not impact product supply and availability in Europe and the rest of the world. It does not change previous assessments made by the European and other international authorities regarding the cold chain storage process.”
More than 50 000 patients are being treated by Neupro in Europe. In the U.S., a Patient Access Program is ongoing and UCB will continue this program.
“We have already been working on a room-temperature stable, improved formulation of Neupro and have made significant progress in this area,” the Chief Medical Officer of UCB added. “Neupro has made a meaningful difference for many people with Parkinson’s disease and Restless Legs Syndrome. We are committed to obtaining FDA approval so that people in the U.S. who live with these diseases can benefit from Neupro.”
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