Aduhelm, Alzheimer’s New Drug

The Food and Drug Administration on Monday approved the first new medication for Alzheimer’s disease in nearly two decades, a contentious decision made despite opposition from the agency’s independent advisory committee and some Alzheimer’s experts who said there was not enough evidence that the drug can help patients.

The drug, aducanumab, which will go by the brand name Aduhelm, is a monthly intravenous infusion intended to slow cognitive decline in people with mild memory and thinking problems. It is the first approved treatment to attack the disease process of Alzheimer’s instead of just addressing dementia symptoms.

FDA approved Aduhelm to treat patients with Alzheimer’s disease using the Accelerated Approval pathway, under which the FDA approves a drug for a serious or life-threatening illness that may provide meaningful therapeutic benefit over existing treatments when the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients and there remains some uncertainty about the drug’s clinical benefit.

This approval is significant in many ways. Aduhelm is the first novel therapy approved for Alzheimer’s disease since 2003. Perhaps more significantly, Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid beta plaques in the brain. The clinical trials for Aduhelm were the first to show that a reduction in these plaques—a hallmark finding in the brain of patients with Alzheimer’s—is expected to lead to a reduction in the clinical decline of this devastating form of dementia.

FDA said: 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. Finally, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.

Although the clinical trials were conducted on specific populations of patients — those with mild cognitive impairment or early-stage Alzheimer’s whose brains contained higher-than-normal levels of amyloid — the F.D.A.’s label for the drug does not contain any such restrictions. The label simply says the drug is “for the treatment of Alzheimer’s disease.”

In 2012, the FDA revoked its approval of the drug Avastin as a breast cancer treatment after additional studies did not show enough benefit. But some other cancer drugs have retained approval even though additional trials failed to confirm the drugs were beneficial. The agency has also been criticized in the past for failing to make sure the follow-up studies are done.

Alzheimer’s trials are already challenging to conduct because it is often difficult to recruit enough participants. Because the condition can progress very gradually, trials need to be large and continue for many months in order to be able to see if a drug is slowing cognitive decline.

Wednesday, 9 Jun, 2021


 Food and Drug Administration

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