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.
   

• MS Walking Improvement Drug Receives Negative FDA Review

  By MATTHEW PERRONE (AP) – 2 days ago WASHINGTON — Shares of Acorda Therapeutics plummeted Friday after the Food and Drug Administration issued a negative opinion that [...]

  • Caroline says: I think a lot of people were excited about this drug...it had a huge amount of press so this is a bummer for many people. The risk of seizure is an issue with doses above 10mg. This means that the drug can still be approved by the FDA, but it may have a "black box" warning about seizures. The FDA will complete its review Oct 22, 2009.