US FDA Still Mulling Over Biogen ALS Treatment Approval Despite Disappointing Phase III Results

March 20, 2023

Briefing documents from a US Food and Drug Administration (FDA) advisory committee show that Biogen’s ALS drug tofersen is still in the running for approval despite a recent failure in a Phase III trial. The favorable outlook is due, in part, due to its effects on reducing a key protein hallmark of the progressive disease.

According to Max Gelman, “The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease”

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(Source: Endpoints News, March 20th, 2023)

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