An FDA advisory committee is set to meet this week to discuss a drug developed by Biogen and Ionis to treat a rare form of Lou Gehrig's disease.
It appears likely that a new drug to treat amyotrophic lateral sclerosis will get approval in the U.S. Regulators shared their thinking ahead of an advisory committee meeting.
The Food and Drug Administration committee is scheduled to meet Wednesday to discuss Biogen Inc. BIIB and Ionis Pharmaceuticals Inc.’s IONS tofersen as a treatment for a rare type of ALS that is associated with the superoxide dismutase 1 gene. Wall Street analysts largely view the approval of tofersen as likely. However, most analysts say they don’t expect this drug to drive the kind of impact they’re looking for on Biogen’s business. Instead, all eyes remain on lecanemab, Biogen and Eisai’s 4523 treatment for Alzheimer’s disease, which received accelerated approval in January.
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