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Biogen halts observational post-marketing study of aducanumab

By Brian Buntz | June 23, 2022

Biogen in the Drug Discovery & Development Pharma 50Biogen (Nasdaq:BIIB) has terminated a study of the controversial Alzheimer’s disease drug Aduhelm (aducanumab) as a result of limited national policy for coverage.

In a listing on clinicaltrials.gov, the company notes that it anticipates there will limited prescriptions of the drug in routine clinical practice, which would provide limited enrollment for the planned ICARE AD study.

The study would have been a prospective, single-arm, multicenter study of aducanumab with up to 5 years of follow-up. The study would have collected data via routine visits every 6 to 12 months, but after opening up recruitment in November, only 29 volunteers had enrolled, according to data posted on clinicaltrials.gov.

Biogen and its partner Eisai (TYO:4523) announced their plans to launch the observational study in a presentation at the July 2021 Alzheimer’s Association International Conference. The drug had won FDA approval a month earlier.

Biogen still has a Phase 4 confirmatory ENVISION study underway.

BIIB shares were up 2.12%, closing at $211.38.

The so-called amyloid hypothesis initially attracted considerable attention from pharma companies eager to develop drugs that reduce the formation of protein in Alzheimer’s disease patients.

Aducanumab was the first amyloid beta-protein inhibitor to win FDA approval.

Last week, Roche (SIX:RO, ROG; OTCQX:RHHBY) subsidiary Genentech announced disappointing results from a study of a similar drug, crenezumab, which failed to show statistically significant clinical benefit in Alzheimer’s patients.


Filed Under: Neurological Disease, Psychiatric/psychotropic drugs
Tagged With: Aducanumab, Alzheimer's disease, Biogen
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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