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Biogen ALS Drug Granted FDA Priority Review, Triggering Aduhelm Déjà Vu

 
• By Jessica Merrill

FDA accepted the NDA for tofersen based on a surrogate biomarker after a Phase III trial failure, echoing some elements of the Aduhelm experience, though in this instance the target patient population is ultra-niche.

train track
Biogen's tofersen NDA follows a familiar track • Source: Shutterstock

The US Food and Drug Administration has accepted a new drug application for Biogen, Inc.'s tofersen for superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS) based on a novel surrogate biomarker, a decision that surprised investors coming after a Phase III clinical trial failure, and echoing some elements of the controversial Aduhelm review.

The FDA granted priority review for the application and set an action date of 25 January, Biogen announced 26 July

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