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Third Member of FDA Panel Steps Down over Biogen’s Alzheimer’s Drug Approval Controversy 

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.

He wrote in the letter that he was very clear that FDA was not adequately integrating its scientific recommendations while making the approval decisions.This will undermine the public trust in the FDA, hamper the health of the patients, and the affordability of the health care system.The market shares of Biogen had surged to 38% after the approval of the drug from the FDA.

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.

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