×
Newsmax TV & Webwww.newsmax.comFREE - In Google Play
VIEW
×
Newsmax TV & Webwww.newsmax.comFREE - On the App Store
VIEW
Tags: alzheimers | drug | aduhelm | biogen

Biogen to Withdraw Alzheimer's Drug Application in Europe

MRI scan of brain labeled Alzheimer's disease
(Dreamstime)

Friday, 22 April 2022 09:53 AM EDT

Biogen Inc said on Friday it has decided to withdraw the marketing authorization application for its troubled Alzheimer's drug, aducanumab, in Europe after it failed to convince the regulator of the drug's benefits.

The drugmaker said the move follows its interactions with the European Medicines Agency that suggested data provided so far would not be enough to support an approval. The agency had in December rejected the drug and Biogen had sought a re-examination of its decision.

"We stand by the safety and efficacy of aducanumab, and we look forward to upcoming data readouts to continue to provide important information on the science of this new class of compound," said Priya Singhal, interim head of R&D at Biogen.

The drug is only approved in the United States, a controversial decision since only one of two late-stage trials showed that it helped slow cognitive decline. The U.S. approval was based on the drug's ability to clear amyloid plaque from the brain, which believes could likely help slow cognitive decline for Alzheimer's patients. But critics and the U.S. Centers for Medicare and Medicaid Services (CMS) did not agree with the decision.

CMS earlier this month limited the drug to patients in clinical trials, significantly restricting its use. Analysts expect minimal sales of the drug in the next few years.

© 2022 Thomson/Reuters. All rights reserved.


Health-News
Biogen Inc said on Friday it has decided to withdraw the marketing authorization application for its troubled Alzheimer's drug, aducanumab, in Europe after it failed to convince the regulator of the drug's benefits.The drugmaker said the move follows its interactions with...
alzheimers, drug, aduhelm, biogen
217
2022-53-22
Friday, 22 April 2022 09:53 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