FDA delays review of Biogen's tofersen

The US Food and Drug Administration (FDA) has extended the review period of the new drug application (NDA) for tofersen by three months.

Under development at US biotech major Biogen (Nasdaq: BIIB), tofersen is an investigational treatment for superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). The updated Prescription Drug User Fee Act (PDUFA) goal date is April 25, 2023.

As part of the ongoing review, Biogen submitted responses to information requests by the FDA which the FDA considered a major amendment to the application that will require additional time for review.