The idea of ​​dynamic approval came to a head towards the end, Dr. Raised by Rick Pazdur, head of the FDA’s oncology center, was not a member of the council. It was not discussed in detail, but after the meeting, when the standard approval was rejected by the council, the only way to make the drug available was to get accelerated approval.

On April 26, Dr. Patrizia Cavazoni, Dr. Dunn’s boss and director of the Center for Drug Evaluation and Research, Vega, chaired a small meeting on approval, which was never used for Alzheimer’s drugs.

In fact, the latest guideline for Alzheimer’s drugs by the FDA, which was issued by D issued. In 2018, Dunn says, “despite extensive research, the” standard for rapid clearance “has not been found for the disease. Doing so is likely to predict clinical benefit. “

And at the November Advisory Committee meeting, Drs. “We’re not using amyloid as a surrogate for efficacy,” Dunn said, considering whether to approve educanumab.

Under accelerated approval, when a drug is on the market, the company will have to conduct an additional trial, an expensive undertaking. Biogen said his goal is standard approval, which he believes his data is secure.

At the April 26 meeting, Dr. Cavazoni did not invite two officers not involved with neurological drugs who repeatedly used acceleration approvals: Drs. Pazdur and Dr. Peter Marks, top vaccine regulator. He and Dr. Cavazoni voted for Adukanumab to grant such approval, said Dr. Issam Zineh, Director of Pharmaceutics, and Dr. Jacqueline Corrigan-Kurre, who led the internal review of the FDA-Biogen collaboration.

Dr. Director of the Office of Translation Science. Shavery Buckman-Garner – who oversees both the pharmacology and biostatistics office fees – did not vote yes or no, saying she understood both arguments. FDA documents say not the only clear vote, said Dr. Silva Collins, director of the Office of Biostatistics Office Fees, “stated that she believes there is insufficient evidence to support acceleration approval or any other type of approval.”