FDA Decision Next Up for Acorda: BioBuzz

HAWTHORNE, NY (TheStreet) -- In the end, the vote wasn't even close. By a 12-1 margin, a panel of experts convened by the Food and Drug Administration recommended approval of a drug from Acorda Therapeutics(ACOR) that helps multiple sclerosis patients to walk.

With the panel recommendation set, Acorda now waits for the final FDA decision on its drug, known as Amaya.

The positive outcome of the advisory panel meeting Wednesday came despite a more skeptical review of Amaya by the FDA's own medical reviewers. That review was posted to the agency's web site Friday and caused shares of Acorda to fall going into the panel meeting.

In a signal that the FDA wasn't necessarily of one mind on the risk-benefit of Amaya, however, the agency added an unusual disclaimer to its own review stating that the negative conclusions expressed did not necessarily reflect the overall view of the FDA.

In another 12-1 vote, the panel did recommend that Acorda test a lower dose of the drug, but by a 10-2 margin, the panel said the low-dose studies could be done after Amaya was approved.

Much discussion was given to a risk-management plan for Amaya, which would warn patients and doctors about the drug's safety risks, including seizures.

The final decision on Amaya's approval is made by FDA, which has a deadline of Oct. 22. That decision will likely be delayed, however, given the timing of Wednesday's panel and the likely need to finalize discussions over the drug's labeling and risk-management plan. An approval delay into early next year may not hurt Acorda's stock price since it is widely expected.