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 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.
More about the decision
More about Amaya (fampridine)
More about gait problems in MS