February 1, 2024: Biogen, a US-based biotechnology company, will discontinue the development and commercialisation of its Alzheimer’s treatment and terminate its post-approval study as it failed to rope in a partner to cut costs of obtaining standard regulatory approval.
The company will stop selling its Aduhelm injection and terminate the additional study that regulators required before they would consider full approval, according to a company statement.
Biogen was concerned that by the time Aduhelm received standard approval, other medicines would have advanced in the market. The treatment was heavily restricted in the US market and faced controversy over patient benefits.
The USFDA gave accelerated approval to Aduhelm in 2021.
In January 2023, Biogen began a strategic review of its research and development efforts, including seeking potential partners or external financing for Aduhelm, as part of a focus on prioritising the company’s portfolio, according to the statement.
“During this process, Biogen considered the time and investment required for the post-marketing confirmatory study and the likely advancements in the field by the time of potential Aduhelm FDA traditional approval.
“Despite an extensive process, the company did not identify potential strategic partners or external financing.”
The decision to stop the treatment “is not related to any safety or efficacy concerns. A large portion of the resources released resulting from the termination of the program will be redeployed, according to the statement.
Biogen will hand back the Aduhelm rights to Neurimmune, from which it had licensed the drug in 2007. It will record a one-time charge of $60 million in the fourth quarter related to the decision to terminate the study and all Aduhelm sales efforts. The rights to aducanumab will revert to Neurimmune.
“We plan to further advance the launch of Leqembi, together with Eisai, and continue to bolster innovation with the development of the other assets in our pipeline,” said Christopher A. Viehbacher, President and Chief Executive Officer of Biogen.
“When searching for new medicines, one breakthrough can be the foundation that triggers future medicines to be developed. Aduhelm was that groundbreaking discovery that paved the way for a new class of drugs and reinvigorated investments in the field.”
Priya Singhal, M.D., M.P.H., Head of Development at Biogen said her company had gained “significant insight” from the development of Aduhelm. Biogen “will carry this forward as we continue our pioneering work in Alzheimer’s disease.”
The company will continue to advance Leqembi — the first anti-amyloid beta treatment with FDA traditional approval in the US.
It will accelerate the development of potential new treatment modalities, including its treatments targeting tau, a protein associated with Alzheimer’s disease.
Japanese partner Eisai will lead Leqembi’s development and regulatory submissions globally with both Eisai and Biogen commercialising and co-promoting the product. Eisai will have the final decision-making authority.
Alzheimer’s disease is the most common form of dementia, affecting 5.2 million Americans over the age of 65, as well as hundreds of thousands under the age of 65 who have early-onset Alzheimer’s, according to Johns Hopkins University. Women account for almost two-thirds of Americans with Alzheimer’s disease.