SHR-1707

Aduhelm garnered a polarised response when the US Food and Drug Administration (FDA) speedily approved it for the treatment of Alzheimer’s disease in June 2021. Image credit: Shutterstock/Melnikov Dmitriy. In a major shift, Biogen will end development and give up the rights of its controversial Alzheimer’s drug Aduhelm (aducanumab-avwa). Biogen is cutting ties with the monoclonal antibody, which could have potentially been a blockbuster for the US-based biotech, after “reprioritising resources”, Biogen CEO Christopher A Viehbacher said in a 31 January press release. Aduhelm garnered a polarised response when the US Food and Drug Administration (FDA) speedily approved it for the treatment of Alzheimer’s disease in June 2021. However, it was soon mired in controversies surrounding its efficacy that limited its reimbursement and access . Now, Biogen is redirecting all resources to its other lead asset Leqembi (lecanemab-irmb). Biogen said it has terminated the licence agreement for the drug, with rights now reverting to the original owner, Swiss biopharma Neurimmune. Biogen has taken a $60m charge in Q4 2023 as a result of dropping the programme. The ENVISION clinical study (NCT05310071), a post-marketing confirmatory trial for the drug, has also been discontinued. See Also: Vertex aims for approval after Phase III win with non-opioid pain reliever SHR-1707 by Jiangsu Hengrui Medicine for Alzheimer’s Disease: Likelihood of Approval Along with putting most of its eggs into the Leqembi basket, Biogen will increase work on its antisense oligonucleotide targeting tau candidate (BIIB080) and an oral small molecule inhibitor of tau aggregation, BIIB113 . Both assets are currently in Phase I trials. Viehbacher added: “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.” The resource-shifting move comes after a strategic review by the company which began in January 2023. With no luck in finding partners or external financing, the decision to drop Aduhelm was made after Biogen “considered 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”, the company stated in the press release. Unlike the accelerated approval Aduhelm received, anti-amyloid beta treatment Leqembi won full FDA approval in July 2023. It marked the first time a drug that slows the progression of the disease was granted a comprehensive regulatory greenlight. The injection was developed with Biogen’s Japanese partner Eisai. In the case of Aduhelm, a major source of controversy surrounded efficacy concerns. Despite an FDA advisory panel voting against the approval, the FDA waved the drug through to market via its accelerated approval pathway, which necessitated a confirmatory trial like ENVISION. Following panel member resignations and an investigation into the approval by the US Department of Health and Human Services, the drug created mounting issues for Biogen. The polarised opinion was no more demonstrated when the European Medicines Agency (EMA) refused marketing authorisation for Aduhelm in December 2021, meaning while Alzheimer’s patients in the US could take the drug, those in Europe could not. The Centers for Medicare & Medicaid Services (CMS) said it would cover the drug but with stringent limitations – namely restricting its use to clinical trials. Aduhelm made just $4.6m in 2022 for Biogen despite a hefty price tag. To add to its woes, the drug created $286m in charges in 2022 for Biogen relating to inventory write-offs and purchase commitments amidst low demand. Leqembi recorded Y400m ($2.7m) in sales for Eisai’s Q2 fiscal year. According to GlobalData’s Pharma Intelligence Centre, Leqembi is forecast to see sales of nearly $6bn by 2029. GlobalData is the parent company of Pharmaceutical Technology. Actioned revival efforts for Biogen started in 2022 when it cut nearly 900 jobs. In August 2023, the company initiated another wave of headcount reduction, targeting 1,000 employees.