Biogen : FDA Extends Review of Tofersen in Rare Form of ALS

By Colin Kellaher

Biogen Inc. on Monday said the U.S. Food and Drug Administration extended its review of its proposed drug for a rare genetic form of amyotrophic lateral sclerosis, or ALS, after the drugmaker submitted more information to the agency.

Biogen said the FDA considers the information, which the Cambridge, Mass., company submitted at the agency's request, a major amendment to its new-drug application for tofersen that will require more time for review.

In July, the FDA granted priority review to Biogen's application seeking approval of tofersen for superoxide dismutase 1 ALS, an inherited form of the fast-moving, paralyzing condition commonly known as Lou Gehrig's disease.

Biogen said the FDA has now extended its target action date for the application to April 25 from Jan. 25.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

10-17-22 0804ET