How to get real Alzheimer’s medicine approved
The idea for speedy approval was briefly drawn to the conclusion, raised by Dr. Rick Pazdor, head of the FDA’s oncology center, who was not a member of the council. It has not been discussed in detail, but after this meeting, after the approval of the Majlis and the rejection of the standard, rapid approval seems to be the only way to make medicines available.
On April 26, Dr. Patricia Kauzoni, President of Dr. Dentris and Director of the Center for Drug Diagnosis and Research, led a small meeting on rapid approval, which has never been used for Alzheimer’s medicine.
In fact, Dr. Dunn’s recent FDA guidelines for Alzheimer’s medicine, released in 2018, say that “rapid approval criteria” for the disease have not yet been met, “despite extensive research. ” The reason, the guide says, is that “unfortunately there is no credible evidence at this time” that attacking amyloid plaques or other Alzheimer’s biomarkers could predict medical rationality.
And at a November advisory committee meeting, Dr. Dunn said, considering whether to approve Advocanaomab, “we are not using amyloid as a surrogate for efficacy.”
Under rapid approval, when a drug is on the market, a company will have to conduct an additional trial, which is an expensive move. Biogen said the goal is standard approval, which he believes confirms the data.
At the April 26 meeting, Dr. Kawazzoni invited two officials who were not involved in the neurosurgery who had frequently used high-speed approvals. He and Dr. Kiva Zoni voted in favor of such an endorsement of Advocateomab, as did Dr. Osam Xenia, Director of the Office of Pharmacology, and Dr. Jacqueline Corrigan Corey, who led the internal review of FDA Biogen Cooperation. ۔
Dr. Shaw Aware Bookman Garner, director of the Office of Translator Sciences – which oversees both the pharmaceutical and biostatistic offices – did not vote on whether or not she understood the two arguments. According to FDA documents, the only clear vote was made by Dr. Silva Collins, director of the Office of Biostatistics, “expressing his conviction that he would support speedy approval or any kind of approval.” There is insufficient evidence. “