Aduhelm's journey to approval was riddled with objections, trove of FDA documents reveal

The FDA's statisticians and advisors repeatedly objected to the approval of aducanumab, Biogen's Alzheimer's drug, according to internal documents the agency released June 22.

On June 7, the FDA approved aducanumab, sold under the brand name Aduhelm, marking the first approval the agency has granted to an Alzheimer's treatment since 2003. Aduhelm is the first treatment approved by the FDA intended to slow cognitive decline from Alzheimer's disease, as the Alzheimer's drugs the FDA previously cleared are aimed at alleviating symptoms rather than slowing the disease's progression.

The newly released documents show that Sylva Collins, PhD, the director of the agency's office of biostatistics, recommended against the approval, as well as several of her colleagues. Their objections mirror criticisms the FDA's peripheral and central nervous system drugs advisory committee expressed in November when it voted against the drugs approval: there is not enough evidence to prove the drug's efficacy.

In a June 7 memo, the FDA's office of neurology summarized the statisticians' recommendations against approval. The statisticians' review examined the conflict between two clinical trials for Aduhelm, one that showed positive results and one that showed little to no efficacy. 

The newly released documents also show senior FDA officials — including Patrizia Cavazzoni, MD, director of drug evaluation; Peter Stein, MD, director of the office of the new drugs; and Billy Dunn, MD, the director of the office of neuroscience — supporting Aduhelm's approval. Their support was based on limited data suggesting the drug reduces amyloid plaque in Alzheimer’s patients' brains.

From June 9-11, three members of the FDA's advisory committee resigned over the approval. 

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