The idea for accelerated approval was raised by Dr. Rick Pazdur, who was not a councilor and head of the FDA’s Center for Oncology, and came to an easy end. No details were discussed, but given that the council rejected standard approval after the meeting, expedited approval seemed 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 small meeting on accelerated approval that has never been used in Alzheimer’s disease drugs.
In fact, the latest in the FDA guidance Regarding the drug for Alzheimer’s disease published by Dr. Dan in 2018, “despite many studies,” the “criteria for expedited approval” have not yet been met for the disease. Guidance states that attacking amyloid plaques or other biomarkers of Alzheimer’s is “unfortunately currently lacking sufficiently reliable evidence” that “it is likely to reasonably predict clinical benefit”. I have.
“We are not using amyloid as a proxy for efficacy,” Dr. Dan said at an advisory board in November when considering whether to approve aducanumab.
With expedited approval, companies have to carry out additional testing while the drug is on the market, which is a costly task. Biogen said its goal is standard approval and believes the data is valid.
At a meeting on April 26, Dr. Cavazzoni invited two non-neurologic staff members who frequently used accelerated approval, Dr. Pazdur and Dr. Peter Marks, the highest vaccine regulator. They and Dr. Cavazzoni voted to give aducanumab such approval, as did Dr. Issam Zineh, director of the Department of Pharmacology, and Dr. Jacqueline Corrigan-Curay, who led an internal review of the FDA-Biogen collaboration. Did.
Dr. Sha Avhrée Buckman-Garner, director of the translation science office, which oversees both pharmacology and biostatistics offices, did not vote for or against, saying he understood both arguments. The only clear negative vote, According to FDA documentsDr. Silva Collins, director of the Bureau of Biostatistics, “stated her belief that there is insufficient evidence to support accelerated approval or other types of approval.”
How Aduhelm, an unproven drug for Alzheimer’s disease, was approved
Source link How Aduhelm, an unproven drug for Alzheimer’s disease, was approved