HAWTHORNE, N.Y., February 2, 2009 Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the submission of a New Drug Application to the U.S. Food and Drug Administration (FDA) on January 30, 2009 for Fampridine-SR, a novel therapy being developed to improve walking ability in people with multiple sclerosis (MS). The Company expects that the NDA filing, if accepted, will be subject to standard review, which would provide a target for the FDA to complete its review within ten months from receipt of the submission.
"This NDA filing is a major milestone for Acorda and our Fampridine-SR development program," said Acorda Therapeutics President and CEO Ron Cohen, M.D. "Walking impairment is one of the most pervasive and alarming aspects of MS for patients, their families and their health care providers. There are no medicines currently indicated to improve walking ability in people with MS, and Fampridine-SR therefore may represent an important new approach to MS therapy. We are excited to have taken this major step toward potentially making Fampridine-SR available to help people with MS."
Approximately 400,000-500,000 people in the Unites States have MS, and recent studies indicate that between 64-85% of people with MS have walking disability1,2. Fully 70% of people with MS who have walking disability report it to be the most challenging aspect of their disease1.
The Fampridine-SR NDA submission is based on data from a comprehensive development program assessing the safety and efficacy of Fampridine-SR, including two Phase 3 trials that involved 540 people with MS and were conducted under Special Protocol Assessments (SPAs) from the FDA. The safety and efficacy profile of Fampridine-SR was consistent across Phase 2 and Phase 3 trials. Overall, the NDA filing included more that 50 clinical studies of Fampridine-SR. The total exposure to Fampridine-SR in MS studies filed as part of the NDA was over 1,200 patient-years. Additionally, more than 450 people are currently enrolled in Fampridine-SR extension trials, with treatment duration ranging from seven months to almost five years.
The Company also has discussed Fampridine-SR with regulatory authorities in Europe and believes that the current data are sufficient to file a centralized Marketing Authorization Application (MAA) with the European Medicines Agency (EMEA). The Company plans to file the MAA when it has determined the commercialization pathway that maximizes the value of Fampridine-SR outside the U.S.
|Contact: Jeff MacDonald|
Ruder Finn Public Relations