FDA delays ruling on Acorda’s MS drug until 1/2010

October 22, 2009 6:38 AM ET HAWTHORNE, N.Y. (AP) – Acorda Therapeutics Inc. said Thursday the Food and Drug Administration delayed a ruling on its multiple sclerosis [...]

• Caroline says: The FDA has delayed their ruling on fampridine-sr, the walking drug from Acorda. The ruling was supposed to be made Oct 22, but Acorda has submitted some new risk-evaluation data so the decision is delayed.
   

• Acorda Announces Positive Vote by FDA Advisory Committee for Fampridine-SR

  Wed, Oct 14, 2009 * Committee Views Fampridine-SR as Safe, Effective and Clinically Meaningful for Improving Walking in People with Multiple Sclerosis * Conference Call Scheduled for [...]

  • Caroline says: Acorda had a special advisory board meeting requested by the FDA to discuss side effect issues in doses above 10mg. The outcome was positive for Acorda: in 10mg doses the drug appears safe and it helps people walk.