How Aduhelm, an Unproven Alzheimer’s Drug, Got Approved
The idea of fast track approval popped up briefly towards the end, brought up by Dr. Rick Pazdur, chief of the FDA oncology center, who was not on the board. This was not discussed in detail, but after the meeting, given the board’s rejection of standard approval, expedited approval appeared to be the only way to make the drug available.
On April 26, Dr Patrizia Cavazzoni, boss of Dr Dunn and director of the Center for Drug Evaluation and Research, led a smaller meeting on expedited approval, which had never been used for drugs against D’s disease. Alzheimer’s.
In fact, the most recent FDA guidelines for Alzheimer’s disease drugs, released by Dr. Dunn in 2018, indicate that the “fast-track standard” had not yet been met for the disease, “Despite a lot of research”. The guide says this is because “unfortunately there is currently no sufficiently reliable evidence” that attacking amyloid plaques or other biomarkers of Alzheimer’s disease “would be reasonably likely to predict clinical benefit. “.
And at the November advisory committee meeting, Dr Dunn said that in considering whether to approve aducanumab, “we are not using amyloid as a surrogate for efficacy.”
In expedited approval, while a drug is on the market, a company has to do an additional trial, an expensive endeavor. Biogen said her goal was standard approval, which she believed her data supported.
At the April 26 meeting, Dr Cavazzoni invited two officials not involved in neurological drugs who had frequently used fast-track approval: 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 Bureau of Pharmacology, and Dr Jacqueline Corrigan-Curay, who led the internal review of the FDA-collaboration. Biogen.
Office of Translational Sciences Director Dr. ShaAvhrée Buckman-Garner – who oversees both pharmacology and biostatistics offices – did not vote yes or no, saying she understood both arguments. According to FDA documents, the only clear vote was that of the director of the Bureau of Biostatistics, Dr. Sylva Collins, “stating her belief that there was not enough evidence to support expedited approval or any other kind. of approval ”.
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