September 26, 2023

The idea of ​​an accelerated approval was briefly suggested towards the end by Dr. Rick Pazdur, the director of the FDA’s oncology center who was not a councilor. It was not discussed in detail, but after the meeting, given the Council’s rejection of standard approval, expedited approval appeared to be the only way to make the drug available.

On April 26th, Dr. Patrizia Cavazzoni, Dr. Dunn’s boss and director of the Center for Drug Evaluation and Research, a smaller session on accelerated approval that has never been used for Alzheimer’s drugs.

In fact, the latest FDA guidelines on Alzheimer’s drugs, published by Dr. Dunn issued in 2018 that “the standard for accelerated approval” for the disease has not yet been achieved “despite extensive research”. The guidelines state that “unfortunately there is currently no sufficiently reliable evidence” that an attack on amyloid plaques or other Alzheimer’s disease biomarkers “would have any likelihood of predicting clinical benefit.”

And at the November Advisory Committee meeting, Dr. Dunn that when considering whether to approve aducanumab, we “don’t use the amyloid as a substitute for effectiveness”.

Accelerated approval requires a company to conduct an additional study while a drug is on the market, an expensive undertaking. Biogen said its goal is to get the standard regulatory approval, which it believes its data is warranted.

At the April 26 meeting, Dr. Cavazzoni appointed two officers who were not involved in neurological drugs and who had frequently used expedited approvals: Dr. Pazdur and Dr. Peter Marks, the leading vaccine regulator. You and Dr. Cavazzoni voted in favor of granting such approval for aducanumab, as did Dr. Issam Zineh, Director of the Office of Pharmacology, and Dr. Jacqueline Corrigan-Curay, who led the internal review of the FDA-Biogen collaboration.

The director of the Translational Sciences Office, Dr. ShaAvhrée Buckman-Garner – who oversees both the pharmacology and biostatistics offices – disagreed with a yes or no, as she understood both arguments. The only clear no, according to FDA documents, was the director of the Biostatistics Bureau, Dr. Sylva Collins, who “stated her belief that there is not enough evidence for accelerated approval or any other type of approval”.