STAT+: FDA advisory panel recommends conditional approval of Biogen’s drug for rare form of ALS
The FDA panel voted 9-0 for conditional approval of Biogen's drug for a rare form of ALS, but split over whether data supported full approval.
An independent panel of advisors to the Food and Drug Administration on Wednesday concluded that a treatment developed by Biogen for a rare, genetic form of ALS should be approved, despite unanswered questions about its benefit to patients.
By a 9-0 vote, the FDA advisory panel said the “totality of the evidence” was sufficient to support conditional approval of the Biogen drug, called tofersen. By a 3-5 vote (with one abstention) the same experts concluded that the tofersen data, including from a failed clinical trial, were not sufficiently convincing to support full approval.
What's Your Reaction?
