BioCentury
ARTICLE | Regulation

A Very Long Walk

October 19, 2009 7:00 AM UTC

Last week's positive vote by an FDA advisory committee on Acorda Therapeutics Inc.'s Fampridine-SR validated the company's work with multiple sclerosis patient groups early in clinical development to identify improved walking ability as a clinically meaningful demonstration of functional gains produced by the compound in MS.

Comments by patients and physicians at the meeting also indicated that the product is likely to enjoy rapid uptake, assuming FDA approves it. Indeed, the clinical community is eager to gain access to a sustained-release, GMP version of 4-aminopyridine (4-AP), which has been available for 15 years as an immediate-release drug from compounding pharmacies...