Congressional investigation into Alzheimer’s drug Aduhelm objects to FDA and Biogen

The FDA’s internal investigation found that there was “no evidence” that its interactions with Biogen were “far from appropriate” given the complexity of the data and the importance of Alzheimer’s, but it issued four recommendations to prevent future problems. The congressional report states that more than a year later, the FDA still hasn’t fully implemented them.

The congressional report also questioned the FDA’s decision to give the drug a special designation known as “expedited approval.” The agency “abruptly changed course,” the report said, after months of claiming Aduhelm would only be considered for traditional approval.

The report, which corroborated previous reports by The Times, said the change came after a council of senior agency officials met to review Aduhelm, also called aducanumab, and unequivocally agreed there was insufficient evidence to support it that it worked. According to minutes of the meeting obtained by The Times, the council said another clinical trial should be conducted first, and one member warned that failing to do so could result in millions of patients taking aducanumab with no evidence of it that they will benefit from it, or worse. To do damage.”

But just three weeks after that meeting, in April 2021, the FDA told Biogen it was now considering Aduhelm for “expedited approval,” allowing approval of drugs of uncertain benefit when they treat serious illnesses with few other options and their biological mechanism It is assumed that there is a reasonable likelihood that patients will be helped. Accelerated approval requires companies to conduct another study, but the report found that the FDA gave Biogen more than eight years to complete it, allowing Aduhelm to be administered to patients during that time.

The agency justified the accelerated approval by saying that Aduhelm targets a protein, amyloid, that forms plaques in the brains of Alzheimer’s patients. But many Alzheimer’s experts said years of data hadn’t shown that reducing amyloid slowed cognitive decline.

The congressional report said it was a “notable error” that the agency failed to convene an independent advisory committee or internal group of experts to consider expedited approval. It also said the agency contradicted its own guidelines for Alzheimer’s drugs, which said “the standard for accelerated approval” for the disease has not yet been met. In its Thursday statement, the FDA said it “plans to update” guidance issued in 2018 “with the goal of further advancing our drug review processes.”

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