×
Newsmax TV & Webwww.newsmax.comFREE - In Google Play
VIEW
×
Newsmax TV & Webwww.newsmax.comFREE - On the App Store
VIEW
Tags: als | amyotrophic lateral sclerosis | biogen | tofersen | fda | accelerated approval

FDA Grants Priority Review to Biogen's ALS Drug

doctor's pad that says diagnosis amyotrophic lateral sclerosis, some pills, thermometer
(Dreamstime)

Tuesday, 26 July 2022 08:34 AM EDT

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.

The drug, tofersen, in October failed to produce a statistically significant change in functional status for patients with fast-progressing ALS compared to placebo after 28 weeks of treatment.

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.

It is a type of mutation that leads to production of more of SOD1 protein that can accumulate to toxic levels in ALS patients with mutations in a specific gene.

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. 

© 2022 Thomson/Reuters. All rights reserved.


Health-News
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. The drug, tofersen, in October failed...
als, amyotrophic lateral sclerosis, biogen, tofersen, fda, accelerated approval
157
2022-34-26
Tuesday, 26 July 2022 08:34 AM
Newsmax Media, Inc.

Sign up for Newsmax’s Daily Newsletter

Receive breaking news and original analysis - sent right to your inbox.

(Optional for Local News)
Privacy: We never share your email address.
Join the Newsmax Community
Read and Post Comments
Please review Community Guidelines before posting a comment.
 
Find Your Condition
Get Newsmax Text Alerts
TOP

The information presented on this website is not intended as specific medical advice and is not a substitute for professional medical treatment or diagnosis. Read Newsmax Terms and Conditions of Service.

Newsmax, Moneynews, Newsmax Health, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, and Newsmax World are trademarks of Newsmax Media, Inc.

NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved
NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved