The idea for accelerated approval came to an end in a nutshell, which was raised by Dr. Rick Pazdur, the head of the FDA’s Oncology Center, who was not a member of the council. This was not discussed in detail, but after the meeting, given the rejection of standard approval by the Council, prompt approval appeared to be the only way to make the drug available.
On April 26, Dr. Dunn’s boss and director of the Center for Drug Evaluation and Research, Dr. Patrizia Cavazzoni, led a short meeting about accelerated approval, which had never been used for Alzheimer’s drugs.
In fact, the FDA’s most recent guidance For Alzheimer’s drugs, released by Dr. Dunn in 2018, the “standard for rapid approval” had not yet been met for the disease, “despite considerable research.” The guidance says this is because “unfortunately there is currently no sufficient reliable evidence” that attacking amyloid plaques or other biomarkers of Alzheimer’s “would be a reasonable probability of predicting clinical benefit.”
And at the November advisory committee meeting, Dr. Dunn said that in considering approving aducanumab, “we are not using amyloid as a surrogate for efficacy.”
Under accelerated approval, while a drug is on the market, a company must conduct an additional test, a costly undertaking. Biogen said its goal was standard approval, which it believed its data warranted.
At the April 26 meeting, Dr. Cavazzoni invited two officials not involved with neurologic drugs who often used quick approvals: Dr. Pazdur and top vaccine regulator Dr. Peter Marx. He and Dr. Cavazzoni voted to approve aducanumab as did Dr. Issam Zineh, director of the Office of Pharmacology and Dr. Jacqueline Corrigan-Cure, who led the internal review of the FDA-Biogen collaboration.
The director of the Office of Translational Sciences, Dr. Shavri Buckman-Garner – which oversees both the offices of pharmacology and biostatistics – did not vote yes or no, saying she understood both arguments. only clear no vote, FDA document says, Director of the Office of Biostatistics, Dr. Silva Collins, “states his belief that there is insufficient evidence to support accelerated approval or any other form of approval.”