The US Food and Drug Administration will ask its external experts whether the existing data for Biogen, Inc. and Ionis Pharmaceuticals, Inc.’s Qalsody (tofersen) support either accelerated or regular approval for treatment of a subgroup of amyotrophic lateral sclerosis patients.
Biogen and Ionis are seeking accelerated approval on the basis that tofersen-driven reductions in plasma neurofilament light chain (NfL) are reasonably likely to predict clinical benefit in patients with ALS
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