Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Views
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

Cleveland Clinic, Mount Sinai decide to not use aducanumab for the foreseeable future

The news is the latest potential hurdle for the drug, which promises to be a blockbuster.

By Brian Buntz | July 15, 2021

Biogen/EisaiThe drama surrounding the Alzheimer’s drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) continues with the Cleveland Clinic and Mount Sinai refusing to use it until more data are available. 

The company’s stock dropped 6.79% to $328.16. 

After FDA decided to conditionally approve the drug for Alzheimer’s disease, three members of an FDA advisory committee have resigned, and politicians and advocacy groups such as Public Citizen have asked for the resignations of senior FDA officials.

FDA recently agreed to narrow the indication for the drug to focus on patients with milder forms of the disease. FDA itself has called for an independent review of its dealings with Biogen leading up to its approval of the drug.

Some internal staff members at FDA have also expressed reservations about the approval, according to The Wall Street Journal. 

The Institute for Clinical and Economic Review (ICER) has concluded that there is insufficient data to support the drug’s $56,000 per year price tag. Biogen has criticized the analysis.

The Cleveland Clinic said its doctors can still prescribe aducanumab but that patients will need to receive the treatment at an external facility. 

The institution indicated that it could change its mind about the biologic Aduhelm after more data become available. 

Biogen plans on offering assistance to patients who have trouble receiving the drug, which it developed in partnership with Eisai (TYO:4523). 

The Alzheimer’s Association, which supported FDA’s approval of the drug, has called for “timely” and “equitable” patient access to the drug. The organization recently released a statement recommending that CMS consider a National Coverage Determination (NCD) for the drug. According to the organization, an NCD can “help prevent regional and community level disparities” of access to aducanumab. 

Analysts have generally been upbeat about Biogen’s neurodegenerative disease strategy and its competitive standing in the area. 

The company’s focus on biologics has proven profitable in the past. All of the company’s blockbusters, apart from the multiple sclerosis therapy Tecfidera are biologics.  


Filed Under: Drug Discovery, Neurological Disease
Tagged With: Aducanumab, Aduhelm, Alzheimer's Association, Alzheimer's disease, Biogen, Cleveland Clinic, Eisai, FDA, Mount Sinai, Public Citizen
 

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.

Related Articles Read More >

Swissmedic approves first malaria treatment for infants
Korean team reports all-in-one cancer nanomedicine in pre-clinical studies
Nektar’s Phase 2b atopic dermatitis win triggers 1,746% analyst target surge, but legal tussle with ex-partner Lilly could complicate path forward
Dupixent approved to treat bullous pemphigoid
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Views
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE