Biogen announced today that it will stop selling and developing its controversial Alzheimer’s drug Aduhelm in favor of Leqembi, which the biotech company developed in partnership with Japanese pharma company Eisai.
Aduhelm (aducanumab-avwa) is a monoclonal antibody drug designed to target amyloid beta plaques found in the brains of people with Alzheimer’s disease. It was developed by Biogen, also with support from Eisai, and was granted accelerated approval by the FDA in June 2021.
However, the drug has been surrounded by controversy ever since it was approved due to concerns about minimal efficacy. Indeed, the Centers for Medicare & Medicaid Services blocked direct use of the drug and limited it to patients in clinical trials only.
The accelerated approval of Aduhelm was followed early last year by the approval of Leqembi (lecanemab), also an amyloid beta targeted Alzheimer’s drug for people in early stages of the disease. Although in some ways Leqembi is similar to Aduhelm, it achieved much more promising results at Phase III and met both primary and secondary endpoints.
Biogen stated it plans to “reprioritize its resources in Alzheimer’s disease” in today’s press statement. It said it will continue to develop Leqembi and other newer treatments for the disease, such as its tau (BIIB080) targeting ASO and a small molecule it is developing to inhibit tau aggregation. But it will discontinue development and commercialization of Aduhelm and will halt the currently ongoing Phase IV postmarketing ENVISION study, which it emphasizes is “not related to any safety or efficacy concerns.”
Aduhelm was originally developed by Swiss biotech Neurimmune and licensed by Biogen. The rights to the drug will now revert to Neurimmune. Biogen says it will use the money saved by stopping Aduhelm sales and development to boost the rest of its Alzheimer’s pipeline.
“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,” said Christopher Viehbacher, president and 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.”
