The idea of expedited approval came up briefly towards the end, raised by Dr. Rick Pazdur, director of the FDA’s cancer center, who was not a board member. It wasn’t discussed in detail, but after the meeting, since the council rejected standard approval, expedited approval appeared to be the only way to make the drug available.
On April 26, Dr. Patrizia Cavazzoni, Dr. Dunn’s chief and director of the Center for Drug Evaluation and Research, led a smaller meeting on expedited approval, which has never been used for drugs for the disease of Alzheimer’s.
In fact, the most recent FDA guide for Alzheimer’s disease drugs, issued by Dr. Dunn in 2018, says that “the standard for expedited approval” had not yet been met for the disease, “despite a great deal of research.” The guide says this is because “unfortunately there is currently insufficient reliable evidence” that attacking amyloid plaques or other biomarkers of Alzheimer’s disease “has a reasonable chance of predicting clinical benefit.”
And at the November advisory committee meeting, Dr. Dunn said that in considering the approval of aducanumab, “we are not using amyloid as a surrogate for efficacy.”
With expedited approval, while a drug is on the market, a company must conduct additional testing, an expensive undertaking. Biogen said its goal was standard approval, which it believed its data warranted.
At the April 26 meeting, Dr. Cavazzoni invited two officials who were not involved with neurological drugs that had used expedited approval frequently: Dr. Pazdur and Dr. Peter Marks, the main 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 internal review of the FDA-Biogen collaboration.
The director of the office of translational sciences, Dr. ShaAvhrée Buckman-Garner, who oversees the offices of pharmacology and biostatistics, did not vote yes or no, saying he understood both arguments. The only clear vote against, FDA documents saywhat the director of the biostatistics office, Dr. Sylva Collins, “affirming his belief that there is insufficient evidence to support expedited approval or any other type of approval.”