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

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

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