U.S. FDA Grants Priority Review to Biogen’s ALS Drug

by cloudnewsmag

(Reuters) -The U.S. Food and Drug Administration has agreed to review Biogen Inc’s experimental treatment for an inherited form of amyotrophic lateral sclerosis (ALS), after the therapy failed a late-stage study but showed promise in some patients.

In June, the company said data from a follow-on study suggested that early administration of tofersen can benefit people living with ALS who have a genetic mutation called SOD1.

Biogen is seeking approval for tofersen under the FDA’s accelerated approval pathway for treatment of ALS patients. The same pathway was used by the company for its controversial Alzheimer’s Disease drug, Aduhelm, last year.

(Reporting by Mrinalika Roy in Bengaluru; Editing by Shinjini Ganguli)

Copyright 2022 Thomson Reuters.

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