FDA staff says Biogen’s ALS drug may have a ‘clinical benefit’ on a rare form of the disease

CNBC March 20, 2023
Annika Kim Constantino

Key Points

– U.S. Food and Drug Administration staff on Monday said Biogen’s investigational ALS drug may have a “clinical benefit” on a rare and aggressive form of the disease.

– The staff made the conclusion in briefing documents ahead of a meeting on Wednesday when a panel of external advisors will discuss whether to recommend accelerated approval of Biogen’s drug tofersen for the treatment of a rare genetic form of ALS.

– The FDA is slated to make a final decision on whether to approve the drug on April 25.

U.S. Food and Drug Administration staff on Monday said Biogen’s investigational ALS drug may have a “clinical benefit” on a rare and aggressive form of the disease,...

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