Biogen has stopped its confirmatory trial of Aduhelm and will direct resources toward Leqembi and the research of other treatments for Alzheimer’s disease.
Biogen will stop selling its Alzheimer’s drug Aduhelm (aducanumab-avwa) and will focus its resources on Leqembi (lecanemab-irmb) and research of other treatments for Alzheimer’s disease.
Aduhelm had received accelerated approval from the FDA in June 2021, and Biogen was conducting post-marketing confirmatory ENVISION study. The company said in a press release it will stop the ENVISION and direct resources toward other Alzheimer’s programs, including an antisense oligonucleotide licensed from Ionis that targets tau (BIIB080) and an oral small molecule inhibitor of tau aggregation (BIIB113).
Biogen officials said it closed out the Aduhelm program in the fourth quarter of 2023 and ended the license with Neurimmune. In a Securities and Exchange Commission filing in November 2023, Biogen indicated that it had already eliminated is commercial infrastructure for Aduhelm, deprioritized of certain research and development programs. It had previously written off $275 million of inventory related to Aduhelm.
The approval of Aduhelm was controversial right from the start. The FDA had approved the therapy even though an advisory committee in recommended against approval. The late-stage development program consisted of two phase 3 clinical trials. One study met the primary endpoint, showing reduction in clinical decline, while the second trial did not meet the primary endpoint. Additionally, it launched with a high price ($56,000), which was later cut in half.
Aduhelm struggled to find it place in the market, especially after the Centers for Medicare and Medicaid Services (CMS) declined to provide coverage for Alzheimer’s disease without full approval.
Leqembi received accelerated approval in January 2023, with full approval in July 2023. It launched with a list price of $26,500 a year. Leqembi is the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in Alzheimer’s disease. The full approval was based on data from the phase 3 confirmatory Clarity AD clinical trial. In this study, Leqembi reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months. Eisai and Biogen partnered to commercialize and co-promote Leqembi, and Eisai has final decision-making authority.
With the full approval of Leqembi, the Centers for Medicare and Medicaid Services (CMS) agreed to provide coverage to beneficiaries.
Both Alzheimer’s Association and the UsAgainstAlzheimer’s patient groups said in statements that Aduhelm’s approval ushered in a new era for Alzheimer’s patients. Both groups are hopeful about new therapies, including Lilly’s donanemab, which is under review at the FDA. Phase 3 trials showed that donanemab slowed cognitive decline by about 35% for patients at the earliest stages of Alzheimer’s disease.
Biogen’s research in Alzheimer’s is focused on the role of tau protein, which can form tangles that accumulate in brain regions involved in cognition. The accumulation of pathological tau tangles has been shown to lead to neuronal loss. One product is antisense oligonucleotide licensed from Ionis (BIIB080) that is designed to seek out and bind to a mRNA to reduce the tau protein in the brain. In October 2023, Biogen reported data from a phase 1b study that showed favorable trends on multiple exploratory endpoints of cognition and activities of daily living in 46 patients with Alzheimer’s disease.
Another Biogen product in development is an oral small molecule inhibitor of tau aggregation (BIIB113).