FDA Panel Votes 'Yes' on Acorda Drug Efficacy: BioBuzz

Stock quotes in this article: ACOR , BIIB  

(Updated with panel vote below)

HAWTHORNE, N.Y. (TheStreet) -- The FDA advisory panel discussing Acorda Therapeutics'(ACOR Quote) drug Amaya appears to be leaning in the company's favor, according to one analyst watching today's proceedings.

"The discussion from the committee was quite favorable in our view, where it actually seemed the panel had more questions for the FDA's analysis than Acorda's analysis. Based on how the meeting is proceeding thus far, it seems to us that the negative tone by the author of the FDA briefing documents wasn't necessarily shared at higher levels of the FDA," writes JP Morgan's Geoff Meacham in a mid-day note to clients.

The FDA review, posted to the agency's Web site Friday, raised questions about the clinical significance of the Amaya data demonstrating that the drug helps multiple sclerosis patients improve their walking ability.

But in an unusual step, the FDA also added a disclaimer to the top of its review, which states: "The FDA background package often contains assessments and/or conclusions and recommendations written by individual FDA reviewers. Such conclusions and recommendations do not necessarily represent the final position of the individual reviewers, nor do they necessarily represent the final position of the Review Division or Office."

In his assessment of the Amaya panel so far, Meacham said the FDA presentation was more balanced and didn't suggest a bias against approval. He added that experts on the panel had more questions about the FDA review than they did about the efficacy of Amaya.

The advisory panel will vote later today whether or not to recommend Amaya's approval. The final approval decision rests with FDA.

Acorda shares are halted today for the advisory panel meeting.

Update: The panel voted 12-1 in favor of Amaya's efficacy.

-- Reported by Adam Feuerstein in Boston

  • Loading Comments...
  •  

SHARE:

  • email
  • print
  • comment
  • digg
  • delicious
  • linkedin
Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

Recent Comments





Connect with TheStreet

Back to Yahoo

Dow Jones S&P 500 NASDAQ 10-Year Note
10,318.16 1,091.38 2,146.04 33.56
Oil *
77.53
DOWN
14.28
DOWN
3.52
DOWN
10.78
UP
0.07
10 Yr
3.36%
SPDR Gold
112.94
-0.14%
-0.32%
-0.50%
+0.21%
Data delayed 20 minutes

Brokerage Partners

TheStreet Premium Services

All Services