The Third Member of the FDA panel stepped down over the controversy regarding FDA’s approval for Biogen’s drug for Alzheimer’s disease. A professor of medicine at Harvard Medical School, Dr. Aaron Kesselheim, said, in U.S history, it was the worst decision of FDA on Biogen.
According to reports, this has been stated in the resignation letter. The agency, at the last minute, had switched its review to an approval pathway. The drug was to have an effect on the amyloid in the brain. It had reviewed that the drug will aid patients that are suffering from Alzheimer’s disease, he wrote in the resignation letter.
It was the first medication that was cleared by the federal government regulators that are said to slow cognitive decline in patients suffering from Alzheimer’s disease. Also, it is the first medicine in the past two decades found for treating Alzheimer’s disease.The drug produced by Biogen is said to target the beta-amyloid. The beta-amyloid is a sticky compound. The beta-amyloid is found in the human brain who suffers from Alzheimer’s disease. Scientists expect that the drug would play an important role in targeting the compound.