The idea of a quick approval came shortly to the end, raised by Dr. Rick Pazdur, the head of the FDA’s cancer center, who was not a board member. It was not discussed in detail, but after the meeting, due to the board’s refusal to approve the standard, expedited approval seemed to be the only way to deliver the drug.
On April 26, Dr. Patrizia Cavazzoni, Dr. Dunn’s boss and director of the Center for Drug Evaluation and Research, led a smaller meeting about expedited, never-before-used approvals. for the treatment of Alzheimer’s disease.
In fact, the most recent FDA guidance on drugs for Alzheimer’s disease, issued by Dr. Dunn in 2018, states that the “criteria for expedited approval” has yet to be met for the disease, “despite the There’s been a lot of research.” The guidelines say that’s because “unfortunately there is currently no reliable evidence” that attacking amyloid plaques or other biomarkers of Alzheimer’s “would potentially predict clinical benefit.” a reasonable way”.
And at the November advisory committee meeting, Dr Dunn said that when considering approval for aducanumab, “we don’t use amyloid as a substitute for effectiveness.”
Under expedited approval, while a drug is on the market, a company must conduct an additional, costly trial. Biogen says its goal is to approve the standard, which it believes its data is secure.
At the April 26 meeting, Dr. Cavazzoni invited two officials not involved in psychoactive drugs who have already received regular express approvals: Dr. Pazdur and Dr. Peter Marks, the top vaccine administrator. head. They and Dr. Cavazzoni voted to approve such aducanumab, Dr. Issam Zineh, Director of the Office of Pharmacology, and Dr. Jacqueline Corrigan-Curay, who led the internal review of the FDA-Biogen partnership. .
The director of the translational science office, Dr ShaAvhrée Buckman-Garner – who oversees both the pharmacology and biostatistics offices – did not vote yes or no, saying she understood both arguments. The FDA document says the only person without a clear vote was the director of the biostatistics office, Dr Sylva Collins, “who said she believes there is insufficient evidence to support expedited or irregular approvals. any other kind of approval”.