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FDA approves aducanumab, a first disease-modifying treatment for Alzheimer's disease

Monday 07 June 2021

In a hotly-contested and keenly-awaited decision, the U.S Food and Drug Administration (FDA) has approved aducanumab for the treatment of Alzheimer's disease (AD).  Aducanumab, which will be sold by Biogen under the name "Aduhelm", is the first Alzheimer's disease treatment to be approved by the FDA since 2003, and is the first potentially disease-modifying therapy to reach the market.

Aducanumab, a monoclonal antibody to beta-amyloid, has been evaluated in several trials on mild cognitive impairment and mild AD.  These trials, which included the Phase 3 EMERGE and ENGAGE trials, were designed to test whether aducanumab could help clear amyloid plaques from the brain, and reduce the progressive cognitive impairment associated with the development of AD. Although the cognitive test data from these clinical trials were ambiguous, data from brain imaging scans consistently showed a reduction in amyloid plaque load following intravenous (IV) administration of high-dose aducanumab. In their press release, the FDA stated that their decision to approve aducanumab via the "Accelerated Approval" pathway was primarily based on this reduction in amyloid plaques, which, it is hoped, will also result in clinical benefit. Rather than limiting the approval to people with mild cognitive impairment or mild AD, the FDA has chosen to approve the therapy broadly, for people at all AD stages.

Biogen are now required to conduct a post-approval clinical trial to verify the anticipated benefit of aducanumab, which is delivered via monthly IV infusions and involves regular monitoring via brain scans. If this trial does not confirm that aducanumab is beneficial for people with AD, the FDA has the possibility of removing the drug from the market. Biogen has determined a list price of USD56,000 per year for the drug, with this price set for the next four years.

Aducanumab is currently under review at the European Medicines Agency (EMA) and at Swissmedic, following submissions by Biogen in October 2020 and April 2021, respectively.