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Biogen refocuses its Alzheimer’s strategy

Part of Biogen’s prioritisation of its portfolio includes focusing on the advancement of its leading anti-amyloid beta Alzheimer’s treatment, LEQEMBI® (lecanemab-irmb).

Biogen Alzheimer'sBiogen Alzheimer's

Credit: Tada Images / Shutterstock.com

Biogen is planning to reprioritise its resources allocated to ADUHELM® (aducanumab-avwa), to advance its Alzheimer’s treatment LEQEMBI® (lecanemab-irmb) and to develop new treatment modalities.

The company stated that it will discontinue the development and commercialisation of ADUHELM 100 mg/mL intravenous injection and will terminate the corresponding Phase III ENVISION clinical study.

Biogen’s decision

A strategic review of the company’s R&D work evaluated the time and investment required for the post-marketing confirmatory ENVISION study and the likely advancements in the field by the time of potential ADUHELM FDA traditional approval, Biogen explained. However potential strategic partners or external financing were not identified.

ADUHELM was the “groundbreaking discovery that paved the way for a new class of drugs and reinvigorated investments in the [Alzheimer’s] field,” commented Christopher Viehbacher, President and Chief Executive Officer of Biogen.

A fresh perspective

Supporting the advancing of Alzheimer’s treatment

“We have gained significant insight from the development of ADUHELM and will carry this forward as we continue our pioneering work in Alzheimer’s disease,” stated Dr Priya Singhal, MPH, Head of Development at Biogen.

ADUHELM received accelerated approval from the US FDA in June 2021, Biogen confirmed. The Phase IV post-marketing confirmatory ENVISION study was required to obtain US FDA accelerated approval of ADUHELM.

Biogen shared that rights to aducanumab will be reverted to Neurimmune.

However, Biogen noted that while the move is not a result of safety or efficacy concerns, a “large portion” of the resources will be diverted in Biogen’s Alzheimer’s disease franchise. For example, LEQEMBI was the first anti-amyloid beta treatment to be granted traditional US Food and Drug Administration (FDA) approval. 

Eisai is leading development of LEQEMBI and regulatory submissions globally. Eisai and Biogen are co-commercialising and co-promoting the treatment. On 9 January 2024, Eisai confirmed that LEQEMBI was approved in China to treat Alzheimer’s. This follows granting of a marketing authorisation for the antibody therapy in Japan in September 2023.

FDA grants accelerated approval for Leqembi