FDA approves Ampyra
ROCKVILLE, Md. The Food and Drug Administration has approved a new drug for improving walking ability in adults with multiple sclerosis, the agency announced Friday.
The FDA approved Acorda Therapeutics’ Ampyra (dalfampridine) extended-release tablets, designed to be administered in daily 10-mg doses. The agency’s approval was based on clinical trials that showed patients treated with the drug had faster walking speeds than those who received placebo. Ireland-based Elan will manufacture the drug using its technology platform, while Acorda will market it in the United States. Biogen Idec will market it in other countries.
“Trouble with walking is one of the most debilitating problems people with MS face,” FDA Center for Drug Evaluation and Research Division of Neurology Products director Russell Katz said.