After contentious debate, FDA approves first Alzheimer's drug since 2003

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On Monday, the US Food and Drug Administration granted approval to a keenly-watched Alzheimer's drug, aducanumab, developed by the drugmaker Biogen. The decision to approve the drug, which was once abandoned as a failure, has been the subject of debate within the scientific and regulatory community for months. Aducanumab, which will be marketed as Aduhelm, […]
On Monday, the US Food and Drug Administration granted approval to a keenly-watched Alzheimer's drug, aducanumab, developed by the drugmaker Biogen. The decision to approve the drug, which was once abandoned as a failure, has been the subject of debate within the scientific and regulatory community for months.

Aducanumab, which will be marketed as Aduhelm, is the first novel Alzheimer's treatment to be approved since 2003, the FDA noted in a press release. Aducanumab is also the first novel treatment designed to address one of several proposed underlying causes of Alzheimer's: the buildup of beta-amyloid plaques in the brain that disrupt the communication of neurons.

Critically, the drug received a conditional form of FDA approval called the 'Accelerated Approval Program.' The accelerated approval pathway is designed to provide early access to drugs for serious conditions if they address markers of disease – even when the FDA has misgivings about the overall results of clinical trials. Because of this, Biogen will still have to conduct a post-approval confirmatory trial of aducanumab.

"If the drug does not work as intended, we can take steps to remove it from the market. But hopefully, we will see further evidence of benefit in the clinical trial and as greater numbers of people receive Aduhelm," the FDA statement reads.

TechCrunch has contacted Biogen for comment on the upcoming confirmatory trial, and will update this story with Biogen's response.

The use of the accelerated approval pathway is clearly intended to address lingering controversies that have plagued aducanumab in the months leading up to the FDA's ruling.

In early-stage trials, there were promising signs that aducanumab might slow cognitive decline, a major Alzheimer's symptom. In a 2016 trial published in the journal Nature, 125 patients with mild or moderate Alzheimer's who received monthly infusions of the drug saw levels of plaques decrease, as did symptoms of cognitive…
Emma Betuel
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