Biogen Closes The Book On The Aduhelm Saga

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Biogen will end the development and commercialization of Aduhelm, the first anti-amyloid antibody drug to reach the US market for Alzheimer’s, including the confirmatory ENVISION trial. Product’s legacy includes an FDA that appears less enthusiastic about accelerated approvals for large indications and a CMS that is more interested in label-driven reimbursement decisions.

closed book — Biogen is ending development and commercialization of Aduhelm • Source: Shutterstock

Biogen, Inc.'s decade-long Aduhelm (aducanumab) story line took many twists and turns over the course of its development, capturing national attention in 2021 when the drug became the first anti-amyloid antibody to reach the US market for Alzheimer’s disease on scant efficacy evidence and quickly fading from the spotlight when the hyped commercial launch failed and a second anti-amyloid drug from Eisai Co., Ltd. and Biogen, Leqembi (lecanemab), gained full approval from the US Food and Drug Administration in 2023.

Key Takeaways

Biogen will discontinue the development and commercialization of Aduhelm, including the ongoing Phase IV confirmatory trial ENVISION.

Now, without any fanfare and as many watchers and investors expected, Biogen announced on 31 January that it will discontinue...

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