Aduhelm: Biogen calls a day on controversial Alzheimer’s mAb

Aduhelm (aducanumab) won US Food and Drug Administration (FDA) accelerated approval in June 2021. However, following authorization, the monoclonal antibody (mAb) drug suffered from limited availability due to questions surrounding its efficacy and access barriers imposed by the US government’s Centers for Medicare & Medicaid Services (CMS) program.

However,  the monoclonal antibody (mAb) drug has suffered from limited sales due to questions surrounding its efficacy, along with access barriers imposed by the US government’s Centers for Medicare & Medicaid Services (CMS) program.

In a statement, Biogen said it is abandoning the product and will “reprioritize its resources in Alzheimer’s disease” after an extensive review of its research and development efforts.

While the company considered the time and investment needed for the post-marketing confirmatory study and development required to receive traditional FDA approval, Biogen “did not identify potential strategic partners or external financing.”

All testing and sales of Aduhelm will end, with Biogen taking a one-time $60 million charge in the fourth quarter 2023 to cover close-out costs. Moving forward, the firm will continue to focus on anti-amyloid beta therapy Leqembi (lecanemab), which received accelerated approval for Alzheimer’s disease in January 2023. The drug will be priced at $26,500 per year, roughly half the original price of Aduhelm.

“As a pioneer in Alzheimer’s disease, Biogen is reprioritizing resources to build a leading franchise to address the multiple pathologies of the disease and patient needs. 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 Viehbacher, CEO 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.”

The firm will terminate and return the rights of aducanumab to Neurimmune, the company it licensed the drug from in 2007. Additionally, Biogen was keen to reinforce this decision is “not related to any safety of efficacy concerns.” Most of the resources freed from the shuttering of this program will be “redeployed” in Biogen’s Alzheimer’s business.