Biogen: FDA Extends Review Period Of NDA For Tofersen - Quick Facts

Biogen Inc. (BIIB) announced the FDA has extended the review period of the NDA for tofersen by three months. The updated PDUFA goal date is April 25, 2023. The FDA accepted the tofersen NDA in July under the accelerated pathway and granted priority review.

Tofersen is an investigational treatment for superoxide dismutase 1 amyotrophic lateral sclerosis.

"We are committed to providing any details the agency needs to complete the review of tofersen," said Priya Singhal, Head of Global Safety and Regulatory Sciences and Interim Head of R&D at Biogen.

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