The company will return the licensing rights of the drug and terminate its post-marketing confirmatory ENVISION trial after it failed to find a partner to ease costs of securing standard regulatory approvals
Biogen to end its association with Alzheimer's drug Aduhelm. (Credit: Testalize.me on Unsplash)
Biogen has unveiled plans to end the development and commercialisation efforts of Aduhelm (aducanumab-avwa) and realign its resources in the Alzheimer’s disease (AD) franchise.
The US-based biotechnology company will also return the licensing rights of the drug and terminate its post-marketing confirmatory Phase 4 ENVISION clinical trial.
The move came after Biogen failed to find a partner to ease the costs of securing standard regulatory approvals.
Biogen started a strategic evaluation of its research and development efforts in January 2023 as part of a focus on prioritising the company’s portfolio.
The study included looking for possible partners or external financing for Aduhelm 100mg/mL injection for intravenous use.
Biogen considered the length and cost of the ENVISION trial as well as the anticipated advances in the field by the time of a potential US Food and Drug Administration (FDA) approval for the asset.
The company will return the rights of aducanumab to Neurimmune, from whom it had licensed in 2007.
In 2022, Biogen announced plans to withdraw its regulatory application with the European Medicines Agency (EMA) for Aduhelm.
The EMA had initially rejected the marketing authorisation application (MAA) for the AD drug.
Biogen will redeploy the majority of its resources released from the termination of the Aduhelm programme in its AD franchise.
The company will continue to advance Leqembi (lecanemab-irmb) as the first anti-amyloid beta treatment with FDA traditional approval in the US.
It will also expedite the development of potential new treatment modalities, like an oral small molecule inhibitor of tau aggregation (BIIB113) and an antisense oligonucleotide (ASO) targeting tau (BIIB080).
Biogen president and CEO Christopher Viehbacher said: “As a pioneer in Alzheimer’s disease, Biogen is reprioritising resources to build a leading franchise to address the multiple pathologies of the disease and patient needs.
“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.”