Biogen discontinues Alzheimer’s drug Aduhelm to focus on Leqembi
Ongoing Phase 4 trial that enrolled over 1K patients will be terminated
Biogen is discontinuing development and commercialization of its controversial Alzheimer’s disease treatment Aduhelm (aducanumab) — a move that’s “not related to any safety or efficacy concerns,” the company said in a press release.
Instead, according to Christopher Viehbacher, president and CEO of Biogen, the company is “reprioritizing resources to build a leading franchise” focused on its other approved Alzheimer’s therapy Leqembi (lecanemab), co-developed with Eisai.
Now, resources that were dedicated to Aduhelm will be reallocated to Leqembi, and to “address the multiple [underlying mechanisms] of the disease and patient needs,” Viehbacher 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,” Viehbacher added.
As part of the discontinuation, the ongoing Phase 4 ENVISION clinical trial (NCT05310071) — which had been designed to confirm Aduhelm’s clinical benefit — also will be terminated.
Controversy had marked Aduhelm’s approval in US
Alzheimer’s is marked by toxic clumps of the amyloid-beta and tau proteins in the brain. Both Aduhelm and Leqembi are antibody-based therapies designed to promote the breakdown of amyloid-beta clumps.
The U.S. Food and Drug Administration (FDA) in 2021 granted accelerated approval to Aduhelm as a treatment for early-stage Alzheimer’s.
The accelerated approval pathway allows marketing authorization for drugs based on early clinical data suggesting the treatment is likely effective. Makers of drugs given accelerated approval are required to conduct additional testing to confirm efficacy and obtain full approval.
The FDA’s accelerated approval of Aduhelm made history as the drug became the first amyloid-beta-targeting Alzheimer’s treatment to hit the U.S. market.
“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,” Viehbacher said.
But FDA’s decision also sparked considerable controversy and a congressional investigation, with many experts unconvinced that available clinical data were enough to support the therapy’s efficacy, and questions arising about irregularities during the approval process.
Biogen gave up on any hope of an Aduhelm approval in the European Union in 2022, withdrawing its application for regulatory approval in Europe. Shortly thereafter, amid lagging sales, the company scrapped its U.S. infrastructure for marketing and selling Aduhelm. Restrictive criteria for covering the therapy’s cost had been announced by Medicare just before that decision was made.
Now, the company is abandoning Aduhelm entirely to focus more resources on Leqembi.
Decision on Leqembi in EU expected in coming months
That therapy was given accelerated approval by the FDA in early 2023. Later that year, the accelerated approval was converted to a traditional approval following trial data that demonstrated that Leqembi slowed cognitive decline for people with early Alzheimer’s.
This milestone made Leqembi the first ever Alzheimer’s treatment to receive traditional FDA approval.
Earlier this year, Leqembi was granted regulatory approved in China. Eisai, which is the lead for Leqembi’s development and regulatory submissions globally, expects a decision in the European Union between April and June, should the regulatory committee announce its opinion by March 31.
Biogen had originally acquired rights to Aduhelm under a collaborative development and licensing agreement with Neurimmune, its prior developer. Rights to the therapy will now go back to Neurimmune.
The ENVISION trial, which had enrolled more than 1,000 early Alzheimer’s patients, with an eye toward potentially supporting Aduhelm’s full approval in the U.S., will shut down its more than 200 study sites.
“We have gained significant insight from the development of Aduhelm and will carry this forward as we continue our pioneering work in Alzheimer’s disease,” said Priya Singhal, MD, Biogen’s head of development.
“We’d like to sincerely thank the trial investigators, healthcare providers, advocates, patients and families involved in the development of Aduhelm. We are grateful to Neurimmune for its scientific contributions and collaboration over many years,” Singhal added.
We have gained significant insight from the development of Aduhelm and will carry this forward as we continue our pioneering work in Alzheimer’s disease.
Biogen noted that it had recorded a one-time charge, totaling about $60 million, in the fourth quarter of 2023 to close out the Aduhelp program.
For its part, Neurimmune says it will continue moving forward with Aduhelm.
“We are excited to lead the future development of [Aduhelm],” Fabian Buller, chief business officer of Neurimmune, said in a company press release.
“We aim to develop [Aduhelm-based] therapeutics for early intervention with a focus on subcutaneous [under-the-skin] administrations, and will provide updates on our progress in due course,” Buller added.
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