Hawthorne-based Acorda Therapeutics has received FDA approval for multiple-sclerosis oral treatment AMPYRA.
AMPYRA can improve walking in adults with MS.
More than a decade in the making, AMPYRA, previously named Fampridine-SR, consists of an extended release tablet formulation of dalfampridine.
Ron Cohen, president and CEO of Acorda, lauded the approval as an “important milestone” for those with MS.
“Difficulty walking is often cited by those with MS as one of the most pervasive and challenging aspects of their disease,” Cohen said. “We are enormously gratified to have achieved approval for the only medication indicated to improve walking in people with MS, and we thank all of the clinicians, people living with MS and medical and patient support organizations who joined in this effort over the past decade.”
The company expects to sell AMPYRA this March.
The FDA has granted the treatment orphan drug status for seven years, which maintains market exclusivity.
