Policy, Research

Advisory Committee's Split Decision on Biogen's Tofersen

Ira Loss, EVP Health Care Analyst
22 March 2023

Summary

We expect FDA to grant accelerated approval instead of full approval to Biogen’s (BIIB) tofersen for the reatment of amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene by the April 25 user fee date after the Peripheral and Central Nervous System Drugs Advisory Committee split their votes on the two questions shown below.


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