The Food and Drug Administration sign will be visible outside the headquarters in White Oak, Maryland, on July 20, 2020.
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A third member of the advisory board of the major Food and Drug Administration has resigned from the authorities’ controversial decision to approve Biogen’s new drug for Alzheimer’s disease, Aduhelm.
Dr. Aaron Kesselheim of Harvard Medical School said the agency’s decision on biogen was “probably the worst drug approval decision in US history,” according to a resignation obtained by CNBC.
“At the very end, authorities switched the review to a fast-track approval route, based on the controversial assumption that the effects of drugs on cerebral amyloid are likely to help patients with Alzheimer’s disease,” he said. An advisory board written in the FDA’s resignation from the peripheral and central nervous system.
Biogen’s share surged 38% on Monday after the FDA approved the drug for a biotech company. It was the first drug approved by US regulators to slow cognitive decline in people living with Alzheimer’s disease, the first new drug for the disease, and almost 20 years ago.
The authorities’ decision was a departure from the advice of an independent panel of outside experts who unexpectedly refused to endorse the drug last fall, citing unconvincing data. At that time, the Commission also criticized government staff for what was called an overly positive review of the data.
This is a developing story. Check for updates.
A third member of the prestigious FDA panel resigns from Biogen’s approval for Alzheimer’s disease
Source link A third member of the prestigious FDA panel resigns from Biogen’s approval for Alzheimer’s disease