Driving with Multiple Sclerosis: Can I? Should I?
Osteoporosis and Physical Activity Among NARCOMS ParticipantsPositive Vote by FDA Advisory Committee for Fampridine-SR
Acorda Therapeutics, Inc. recently announced the U.S. Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs (PCNSD) Advisory Committee voted 12 to 1 that clinical data on Fampridine-SR 10 mg twice daily demonstrated substantial evidence of effectiveness as a treatment to improve walking in people with multiple sclerosis (MS) and voted 10 to 2 (1 abstention) that it is clinically meaningful and can be safe for use.
“We are pleased with the outcome of today’s Advisory Committee meeting. People with MS have an urgent need for therapies to improve their walking, which is essential to conducting their activities of daily life. If approved, Fampridine-SR would be the first medicine to improve walking in people with MS,” said Ron Cohen, M.D., Acorda Therapeutics President and CEO. “This Advisory Committee meeting is an important milestone in the development of Fampridine-SR, and we look forward to working with the FDA as it completes its review of Acorda’s New Drug Application.”
The Committee also recommended by a vote of 12 to 1 that Acorda be required to evaluate the effects of doses lower than 10 mg twice daily, but by a 10 to 2 vote (1 abstention) that these studies not be required prior to approval.
At the request of the FDA, the Committee discussed possible conditions for use, including for patients with renal impairment or history of seizure. Acorda has proposed a Risk Evaluation and Mitigation Strategy (REMS) program, which could include healthcare professional and patient education around appropriate use of Fampridine-SR.
The FDA seeks the advice of an advisory committee such as the PCNSD when evaluating a potential new treatment, but is not required to follow its recommendation. The current Fampridine-SR Prescription Drug User Fee Act (PDUFA) date set by the FDA is October 22, 2009; the PDUFA date is the target date for the FDA to complete its review of Fampridine-SR.
It would be helpful if new data could be reported in language that is more easily read by non-medi-techno readers. I understand that establishing the authenticity of the research base, from which the news article is generated, is essential. However, if this could be a concluding reference, with the “meat” of the information transmitted in layman’s language, I believe it would be more conducive to feedback on the information.