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The idea of ​​expedited approval was proposed by the FDA’s oncology center chair and non-council member Dr. It was brought up by Rick Pazdur. It wasn’t discussed in detail, but after the meeting, expedited approval seemed the only way to make the drug available, given the council’s refusal to standardize approval.

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

In fact, the FDA’s latest guidance Dr. For Alzheimer’s drugs, published by Dunn in 2018, he says the “standard of accelerated approval” for the disease has not yet been met, “despite a lot of research.” The guide says this is because “unfortunately, there is currently not enough reliable evidence” that attacking amyloid plaques or other biomarkers of Alzheimer’s would be “reasonably likely to predict clinical benefit.”

And at the November advisory board meeting, Dr. “We don’t use amyloid as a surrogate for efficacy,” Dunn said when considering whether to approve aducanumab.

Under accelerated approval, when a drug is on the market, a company has to do an additional trial, which is a costly undertaking. Biogen said its goal is standard confirmation that it believes its data is warranted.

At the April 26 meeting, Dr. Cavazzoni invited two officials unrelated to neurological drugs who often use expedited approval: Dr. Pazdur and top vaccine regulator Dr. Peter Marks. They and Dr. Cavazzoni, director of the Office of Pharmacology, Dr. Dr. Issam Zineh, who led the internal review of the FDA-Biogen collaboration. They voted for such approval to aducanumab, as did Jacqueline Corrigan-Curay.

The director of the translation sciences office, which oversees both the pharmacology and biostatistics offices, Dr. ShaAvhrée Buckman-Garner did not vote yes or no, saying she understood both arguments. One clear no vote, FDA documents say, director of the biostatistics office, Dr. Sylva Collins stated that she “believes there is insufficient evidence to support expedited approval or any other approval.”