Biogen has announced that it will be discontinuing the development and commercialisation of its Alzheimer’s treatment, Aduhelm (aducanumab-avwa).
The intravenous drug was approved by the US Food and Drug Administration (FDA) in June 2021 under the accelerated approval pathway, a decision that faced controversy as many argued that there was insufficient evidence of patient benefit.
The phase 4 post-marketing confirmatory ENVISION study, which was a requirement of the FDA’s decision, will now be terminated, Biogen said.
The drugmaker outlined that the decision is not related to any safety or efficacy concerns, but that it had “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 said it has recorded a one-time charge of approximately $60m related to closing out costs for the programme in the fourth quarter of 2023 and that it will hand back the Aduhelm rights to Neurimmune, from which it had licensed the drug in 2007.
Affecting more than 6.5 million people in the US, Alzheimer’s disease is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks.
Biogen said it will now focus its efforts on its Eisai-partnered Alzheimer’s drug Leqembi (lecanemab-irmb), as well as potential new treatment modalities.
Leqembi was granted traditional approval by the FDA in July 2023 for use in patients with mild cognitive impairment or early-stage Alzheimer’s disease as a bi-weekly intravenous infusion.
Eisai’s supplemental biologics application for approval under the traditional pathway was supported by data from the phase 3 confirmatory Clarity AD clinical trial, in which Leqembi reduced clinical decline by 27% on the global cognitive and functional scale compared with placebo at 18 months.
Christopher Viehbacher, president and chief executive officer of Biogen, said: “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.
“When searching for new medicines, one breakthrough can be the foundation that triggers future medicines to be developed.”