FDA Pushes Extends Review For Biogen's Amyotrophic Lateral Sclerosis Drug

  • The FDA extended the review period for Biogen Inc's BIIB experimental Tofersen treatment for an inherited form of amyotrophic lateral sclerosis (ALS) by three months.
  • Biogen had submitted responses to the FDA's information requests, which the agency said would require additional time for review, and set a new target action date of April 25, 2023.
  • The agency had accepted Biogen's application for the drug, tofersen, under its accelerated approval pathway in July, with an approval decision expected by January 25, 2023.
  • In October 2021, VALOR did not meet the primary endpoint. However, trends of reduced disease progression across multiple secondary and exploratory endpoints were observed. 
  • Last month, Biogen released a new analysis showing that longer-term use and early initiation of tofersen effectively slowed disease progression.
  • Price Action: BIIB stock is up 0.97% at $267.21 on the last check Monday.
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