Women's Health

Congressional investigation into Alzheimer’s drug Aduhelm slams FDA and Biogen


The FDA’s own internal investigation said there was “no evidence” that its interactions with Biogen were “anything but appropriate”, given the complexity of the data and the significance of Alzheimer’s disease. , but it made four recommendations to prevent future problems. The congressional report said that more than a year later, the FDA still had not fully implemented them.

The Congressional report also questioned the FDA’s decision to give the drug a special designation, known as “fast track approval.” The agency had “suddenly changed course,” the report noted, after months of saying Aduhelm would only be considered for traditional endorsement.

The report, confirming previous reports from The Times, said the change came after a board of senior agency officials met to review Aduhelm, also known as aducanumab, and resoundingly agreed that it there wasn’t enough evidence that it worked. According to meeting minutes obtained by The Times, the board said another clinical trial should be conducted first, and one member warned that otherwise approval could “lead to people taking aducanumab.” million patients with no indication of benefit, or worse, harm. »

But just three weeks after that meeting, in April 2021, the FDA told Biogen it was now considering Aduhelm for “fast track approval,” which allows drugs of uncertain benefit to be cleared if they can treat serious diseases. with few other options and if their biological mechanism is considered reasonably likely to help patients. The accelerated approval requires the companies to conduct another trial, but the report notes that the FDA gave Biogen more than eight years to complete it, allowing Aduhelm to be given to patients during that time.

The agency’s rationale for the expedited approval was that Aduhelm targets a protein, amyloid, that forms plaques in the brains of patients with Alzheimer’s disease. But many Alzheimer’s disease experts have said years of data have not shown that reducing amyloid slows cognitive decline.

The Congressional report said the agency’s failure to reconvene an independent advisory committee or internal expert panel to consider expedited approval was “significant misconduct.” He also said the agency contradicted its own guidelines for Alzheimer’s drugs, which said “the fast-track approval standard” had not yet been reached for the disease. In its Thursday statement, the FDA said it “plans to update” the guidance, released in 2018, “with the goal of continuing to advance our drug review processes.”

The report also looked at the FDA’s initial decision to approve Aduhelm for all patients with Alzheimer’s disease, even though it had only been tested in people in the early, mild stages of the disease. . FDA officials, justifying the decision, told committees that the broad label would have benefits, including allowing patients to continue taking Aduhelm after their early disease worsens.


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