A recent press release from the National MS Society:

“FDA Advisory Panel OK’s Fampridine-SR

First-ever oral medication specifically for MS

Fampridine-SR would treat difficulty walking

On October 14, an FDA advisory committee recommended Fampridine-SR for approval. The FDA is expected to make a final decision on or before October 22. The expected decision will make Fampridine-SR (with the proposed brand name Amaya) the first medication ever approved specifically to treat an MS symptom.

In phase-III clinical trials, Fampridine-SR was found to improve walking speed in people with MS. While the studies mainly measured gait improvement, some participants said they felt less disabled during their daily activities. The drug, developed by Acorda Therapeutics, works by blocking tiny potassium channels on nerve surfaces, which may temporarily enhance nerve signaling.
Jackie Havner and Gracie
Jackie Havner and her granddaughter Gracie. Jackie, diagnosed with MS in 1965, was among the consumers testifying about benefits of Fampridine.

Filling a treatment gap

FDA approval would fill a large gap in current MS treatments, since this drug has shown benefit even in those with primary progressive MS, a form for which there are no approved disease-modifying therapies.

“Although we might think of difficulty walking as an isolated symptom of MS, this is far from true,” said Nicholas LaRocca, PhD, in a statement for the committee. “It affects a large range of everyday activities.” LaRocca is the vice president of Health Care Delivery and Policy Research at the Society.

While the FDA is not required to follow advisory committee recommendations, it almost always does.”

This is especially exciting at my house. My husband has Primary Progressive MS, and this is the very first medication approved for treatment of his disease.

As the press release says, the FDA generally follows the committee recommmendations. However, their final determination won’t come until January:

Acorda Therapeutics Inc. said the Food and Drug Administration delayed a ruling on its multiple sclerosis drug candidate Fampridine-SR by three months.

The agency was due to make a decision by today, 22/10, but the ruling is now due by Jan. 22, 2010.

Acorda said the FDA extended its review because it recently submitted new information on its risk evaluation strategy for the drug.

Acorda sent in the additional information following a meeting with an FDA panel on Oct. 14. The panel recommended that Fampridine-SR receive FDA approval.

Source: The Associated Press Copyright 2009 The Associated Press. All rights reserved. (22/10/09)

Be well.

Related News:

Extavia Approved for Multiple Sclerosis (nlm.nih.gov)

FDA Panel Likes Acorda’s Multiple Sclerosis Drug (blogs.wsj.com)

Novartis study shows promise for oral MS therapy (dailyfinance.com)

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Tags: amaya, fampridine-sr, MS information, ms treatment, multiple sclerosis help, multiple sclerosis news

This entry was posted on Monday, October 26th, 2009 at 9:53 am and is filed under Symptoms And Medical Treatments. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.