The US Food and Drug Administration (FDA) is actively retooling its accelerated approval pathway, with or without actions by Congress. GSK announced yesterday, November 22nd, that the agency asked it to pull a multiple myeloma drug based on negative post-confirmatory trial data. Unlike previous situations of the sort, the agency moved in just over two weeks.
According to Zachary Brennan, “The urgency in the FDA’s request shows the extent to which the agency is becoming more nimble. In other AA cases, such as with the failed confirmatory trial for Covis’ preterm birth drug Makena in 2018, the agency’s ability to pull the drug has been delayed by four years, with a recent hearing that should lead to a final decision in the coming months.”
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(Source: Endpoints News, November 22nd, 2022)