The FDA announced Friday afternoon that it has approved Ampyra (dalfampridine) extended-release tablets to improve walking in patients with multiple sclerosis. In clinical trials, patients treated with Ampyra had faster walking speeds than those treated with a placebo. This is the first drug approved for this use.
"Trouble with walking is one of the most debilitating problems people with MS face," says Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. Ampyra will be manufactured under licenses from Elan and distributed by Acorda Therapeutics.
"The approval of Ampyra marks an important milestone for the many people with MS who suffer walking impairment. Difficulty walking is often cited by those with MS as one of the most pervasive and challenging aspects of their disease," said Ron Cohen, M.D., president and CEO of Acorda Therapeutics, adding "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."
- check out the release from the FDA