Navigation Links
Acorda Therapeutics submits new drug application for Fampridine-SR in multiple sclerosis

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

Related biology news :

1. A novel target for therapeutics against Staph infection
2. Bayhill Therapeutics and the Juvenile Diabetes Research Foundation announce research collaboration
3. Growing fuel and medicine: Advancing biofuels and plant-produced therapeutics
4. Sirtris review of sirtuin therapeutics for diseases of aging in Nature Reviews Drug Discovery
5. Media invitation: 20th EORTC-NCI-ACR Symposium on Molecular Targets and Cancer Therapeutics
6. CU-Boulder, biotech firm team up on python project in search for human cardiac therapeutics
7. Michael J. Fox Foundation PD Therapeutics Conference
8. Galapagos and Cystic Fibrosis Foundation Therapeutics announce drug discovery collaboration
9. ORNL supercomputer simulation wins prize for fastest-running science application
10. Track your fitness, environmental impact with new cell phone applications
11. New filtering technology has environmental, industrial applications
Post Your Comments:
(Date:6/2/2016)... -- The Department of Transport Management (DOTM) of ... US Dollar project, for the , Supply and ... and IT Infrastructure , to Decatur ... of Identity Management Solutions. Numerous renowned international vendors participated in ... was selected for the most compliant and innovative solution. ...
(Date:6/2/2016)... June 2, 2016 Perimeter Surveillance ... Unmanned Systems, Physical Infrastructure, Support & Other Service  ... visiongain offers comprehensive analysis of the global ... will generate revenues of $17.98 billion in 2016. ... Inc, a leader in software and hardware technologies for ...
(Date:5/24/2016)... , May 24, 2016 Ampronix facilitates superior patient care by providing ...  3D medical LCD display is the latest premium product recently added to the range ... ... ... Sony 3d Imaging- LCD Medical Display- Ampronix News ...
Breaking Biology News(10 mins):
(Date:6/27/2016)... ... June 27, 2016 , ... Newly created ... and solutions to the healthcare market. The company's primary focus is on new ... and marketing strategies that are necessary to help companies efficiently bring their products ...
(Date:6/27/2016)... , June 27, 2016   Ginkgo Bioworks , ... industrial engineering, was today awarded as one of ... of the world,s most innovative companies. Ginkgo Bioworks ... for the real world in the nutrition, health ... work directly with customers including Fortune 500 companies ...
(Date:6/24/2016)... ... 2016 , ... While the majority of commercial spectrophotometers and fluorometers use the ... models are higher end machines that use the more unconventional z-dimension of 20mm. ... the bottom of the cuvette holder. , FireflySci has developed several Agilent flow ...
(Date:6/23/2016)... ... June 23, 2016 , ... ... to announce the launch of their brand, UP4™ Probiotics, into Target stores nationwide. ... years, is proud to add Target to its list of well-respected retailers. This ...
Breaking Biology Technology: