After years of speculation, debate, doubt and anticipation, the wait to discover the FDA’s ruling on Biogen’s controversial Alzheimer’s treatment is finally over.
Today, the agency announced that it has approved aducanumab for the treatment of patients with Alzheimer’s disease under its Accelerated Approval pathway. It is the first new Alzheimer’s approval since 2003 and the first time that a disease-modifying drug has ever been approved to treat Alzheimer’s.
Aducanumab — aka Aduhelm — targets the build-up of beta-amyloid plaques on the brain. After early data readouts in March 2019 from two late-stage trials of the drug seemed to show that it did not reduce Alzheimer’s symptoms, Biogen scrapped the drug. Then, a few months later, the company shocked the pharma world by reporting that its original interpretation of the data had been wrong and that the drug did show clinical benefit. Biogen then filed for FDA approval.
Since then, debates about the drug’s effectiveness have been fierce and a November 2020 FDA advisory committee voted resoundingly against its approval. In its announcement of aducanumab’s OK, the FDA acknowledged these concerns, saying:
We are well-aware of the attention surrounding this approval. We understand that Aduhelm has garnered the attention of the press, the Alzheimer’s patient community, our elected officials, and other interested stakeholders. With a treatment for a serious, life-threatening disease in the balance, it makes sense that so many people were following the outcome of this review. Further, the data included in the applicant’s submission were highly complex and left residual uncertainties regarding clinical benefit. There has been considerable public debate on whether Aduhelm should be approved. As is often the case when it comes to interpreting scientific data, the expert community has offered differing perspectives.
The FDA said that aducanumab fit the criteria of the Accelerated Approvals pathways, which is aimed at providing an earlier approval of drugs for serious conditions that have an “unmet medical need.” Under the approval, the agency says that Biogen will be required to conduct post-approval studies to verify “anticipated clinical benefit.” If these studies don’t show benefit, the FDA said the drug could then be pulled from the market.
Read our full report on the history of the aducanumab debate and what’s at stake for Biogen, the FDA and the Alzheimer’s community in our March cover story, “The Alzheimer’s approval maze.”
