Biogen ALS drug considered not effective by FDA advisory panel

Biogen Inc. (BIIB) received a setback late Wednesday after a Food and Drug Administration advisory committee said the biotech drug maker's proposed amyotrophic lateral sclerosis, or ALS, treatment did not show it was effective. On Wednesday, the FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted 5-3 with one abstention that the study did not "provide convincing evidence of the effectiveness of toferson," the name of the treatment for the proposed indication. While the FDA uses the committee's recommendation to decide whether or not to approve the drug, it is not bound by the decision. Biogen shares were up 0.3% after hours, following a 1.9% decline in the regular session to $261.22.

-Wallace Witkowski

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03-22-23 1828ET

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