How an Unproven Alzheimer’s Drug Got Approved

The thought of accelerated approval got here up briefly towards the top, raised by Dr. Rick Pazdur, head of F.D.A.’s oncology middle, who was not a council member. It was not mentioned intimately, however after the assembly, given the council’s rejection of ordinary approval, accelerated approval gave the impression to be the one strategy to make the drug accessible.

On April 26, Dr. Patrizia Cavazzoni, Dr. Dunn’s boss and director of the Center for Drug Evaluation and Research, led a smaller assembly about accelerated approval, which had by no means been used for Alzheimer’s medication.

In truth, the F.D.A.’s most up-to-date guidance for Alzheimer’s medication, issued by Dr. Dunn in 2018, says “the standard for accelerated approval” had not but been met for the illness, “despite a great deal of research.” The steerage says that’s as a result of “there is unfortunately at present no sufficiently reliable evidence” that attacking amyloid plaques or different biomarkers of Alzheimer’s “would be reasonably likely to predict clinical benefit.”

And on the November advisory committee assembly, Dr. Dunn stated that in contemplating whether or not to approve aducanumab, “we’re not using the amyloid as a surrogate for efficacy.”

Under accelerated approval, whereas a drug is available on the market, an organization should conduct an extra trial, a expensive endeavor. Biogen stated its objective was customary approval, which it believed its information warranted.

At the April 26 assembly, Dr. Cavazzoni invited two officers not concerned with neurological medication who had used accelerated approval steadily: Dr. Pazdur and Dr. Peter Marks, the highest vaccine regulator. They and Dr. Cavazzoni voted to grant such approval to aducanumab, as did Dr. Issam Zineh, director of the Office of Pharmacology, and Dr. Jacqueline Corrigan-Curay, who led the interior assessment of the F.D.A-Biogen collaboration.

The director of the workplace of translational sciences, Dr. ShaAvhrée Buckman-Garner — who supervises each the pharmacology and biostatistics workplaces — didn’t vote sure or no, saying she understood each arguments. The solely clear no vote, F.D.A. documents say, was the director of the workplace of biostatistics, Dr. Sylva Collins, “stating her belief that there is insufficient evidence to support accelerated approval or any other type of approval.”

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