Publications
Publications
- June 2023 (Revised July 2024)
- HBS Case Collection
Biogen and the Aduhelm Melee
By: Amitabh Chandra and Lauren Gunasti
Abstract
Alzheimer's Disease is a devastating condition affecting millions of Americans. At this time, there is no cure. In 2021, Biogen's Aduhelm (aducanumab) received FDA approval under the accelerated approval pathway after a controversial approval process.
This case explores Alzheimer's drug development, Aduhelm's clinical trials, FDA regulatory processes, the impact of the disease on payors and the broader healthcare system, and the valuation of an Alzheimer's therapy.
This case explores Alzheimer's drug development, Aduhelm's clinical trials, FDA regulatory processes, the impact of the disease on payors and the broader healthcare system, and the valuation of an Alzheimer's therapy.
Keywords
Health Testing and Trials; Governing Rules, Regulations, and Reforms; Valuation; Product Development; Pharmaceutical Industry
Citation
Chandra, Amitabh, and Lauren Gunasti. "Biogen and the Aduhelm Melee." Harvard Business School Case 623-046, June 2023. (Revised July 2024.)