The FDA has authorised the medicine aducanumab for the treatment of Alzheimer’s disease, according to agency officials on Monday.
According to the FDA, the medicine, marketed under the trade name Aduhelm and made by Biogen, is the first to be authorised for the devastating form of dementia since 2003.
It has been green-lighted over the objections of some experts — including the FDA’s own Peripheral and Central Nervous System Drugs Advisory Committee, which rejected the drug last November — who argue that there is insufficient evidence that it helps patients with the disease, the agency acknowledged.
“We are well-aware of the attention surrounding this approval,” the FDA said in a statement.
However, the agency regulators “concluded that the benefits of [aducanumab] for patients with Alzheimer’s disease outweighed the risks of the therapy,” it said.
According to the FDA, aducanumab is provided as a monthly intravenous infusion and is intended to reduce cognitive loss in persons in the early stages of Alzheimer’s disease who have minor memory and thinking impairments.
It is the first treatment licenced to treat the disease process of Alzheimer’s by lowering the buildup of damaging plaques in the brain, rather than only addressing dementia symptoms, according to the company.
According to the business, Biogen terminated clinical tests for the medicine in 2019 as evidence indicated it wasn’t as beneficial as researchers expected.
And in a commentary published by the journal Alzheimer’s and Dementia in November, a team of physicians who treat patients with the disease said they disagreed with Biogen’s findings and argued against the drug’s approval.
One of the authors of the statement was a member of the FDA board that refused the drug’s clearance.
However, a recent examination of a bigger data set revealed that the medicine “reduced clinical decline” in Alzheimer’s patients, prompting the firm to seek FDA clearance at the time.
These findings, published in May, showed that aducanumab medication delayed cognitive deterioration in persons with Alzheimer’s disease by 22%.
According to the Alzheimer’s Association, an estimated 6 million people in the United States are affected with Alzheimer’s disease, and authorised therapies have offered little, if any, benefit.
Given the mixed results of the clinical trials for the drug, the FDA’s approval is based on the condition that the manufacturer, Biogen, conduct a new clinical trial.
The drug will be available to patients until the post-market study, or Phase 4 trial, is completed, the agency said.
If the trial fails to show that the drug is effective, the agency may reverse its approval, it said.
“Although the [aducanumab] data are complicated with respect to its clinical benefits, FDA has determined that there is substantial evidence that [the drug] reduces amyloid beta plaques in the brain and that the reduction in these plaques is reasonably likely to predict important benefits to patients,” the agency said.
However, “FDA will continue to monitor [aducanumab] as it reaches the market and ultimately the patient’s bedside [and] if the drug does not work as intended, we can take steps to remove it from the market,” it said.