Drugmaker Biogen announced this week that it will abandon the development of Aduhelm, which won conditional FDA approval in 2021. The company will stop all ongoing confirmatory clinical trials and the drug will no longer be sold.
Biogen renounced ownership of their controversial anti-Alzheimer’s drug Aduhelm after years of dismal sales. The company is also halting an ongoing clinical trial set to assess the safety and effectiveness of the drug. The company will continue supplying the drug to patients until November but will stop providing the drug to trial participants in May.
The drug received an accelerated approval in 2021 based on two contradictory clinical studies — one which found the drug had no effect on cognition and another which suggested it slowed cognitive decline by a very small amount. Two FDA advisors quit the panel after the drug was approved and a congressional investigation found that the FDA had held inappropriate closed door meetings with FDA officials. Some clinicians and researchers worried that the risks of brain bleeds and swelling exceeded the benefits of the drug. As a result, the CMS restricted coverage of the drug — which initially cost $56,000 and was later slashed to $28,000 — to clinical trials.
“This decision is not related to any safety or efficacy concerns,” the company stated in a press release.
It explained that the decision was made due to the amount of time and money it would require to run a confirmatory trial for Aduhelm and “the likely advancements in the field” by the time the company can apply for full approval. A Biogen spokesperson declined to clarify what was meant by this statement. They also provided another explanation in the press release: The company also said they didn’t find the right strategic or financial partners to move forward.
“Biogen’s decision to end the sale of aducanumab is the closing thread of a sad story of how the business of medicine distorted care and corrupted science.”
The money earmarked for Aduhelm will now be diverted to Leqembi as well as two early-stage investigational tau-targeting drugs — BIIB080 and BIIB113. Biogen declined to provide a breakdown of how much of these funds will go to Leqembi versus their experimental Alzheimer’s drugs, that may or may not succeed in clinical trials.
“Biogen’s decision to end the sale of aducanumab is the closing thread of a sad story of how the business of medicine distorted care and corrupted science,” Dr. Jason Karlawish, professor of medicine at the University of Pennsylvania told Being Patient.
What happens to patients in these clinical trials?
Some of the patients who received Aduhelm through the ENVISION trial may be eligible to receive other anti-amyloid drugs like Leqembi, according to a Biogen spokesperson. The drug was fully approved by the FDA last year and also covered by Medicare.
“Decisions about treatment are between the individual physicians and their patients,” a spokesperson for Biogen said, adding that whether a patient will switch to Leqembi “is completely up to the individual physicians.”
Some of the data collected during the trial may still prove valuable to researchers in understanding how anti-amyloid drugs work. “We have published a number of publications and will be evaluating opportunities to continue to share learnings from the program, including from ENVISION,” a spokesperson said.
The patient advocacy group Voices of Alzheimer’s expressed concerns “that individuals currently taking Aduhelm will face difficulty in finding new treatment options.”
“We urge Biogen to use this moment to set a precedent for patient care and education in response to discontinuing Aduhelm,” Voices of Alzheimer’s wrote in a public statement. “It is imperative that Alzheimer’s patients and their care partners receive clear and accessible information about this change, centering on the patient experience.”
What’s next in the pipeline for Alzheimer’s patients?
The anti-amyloid drug donanemab is closing out its Phase 3 trials and may receive approval later this year. Alzheon’s amyloid-targeting pill ALZ-801 could also provide a safe alternative for patients with the APOE4 Alzheimer’s gene if it receives approval within the next two years.