STAT+: Expert panel votes down Fibrogen’s anemia pill due to safety risks, making U.S. approval unlikely

A panel of outside experts convened by the Food and Drug Administration concluded Thursday that the risks of blood clots and other safety concerns tied to Fibrogen’s anemia pill were too high to support the drug’s approval for patients with chronic kidney disease.

The FDA is not required to abide by the panel’s recommendations, but the lopsided votes against the Fibrogen drug called roxadustat — backed by strong concerns about its safety in vulnerable patients — makes it all but certain the drug will not reach the market without more data from additional clinical trials.

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STAT+: Expert panel votes down Fibrogen’s anemia pill due to safety risks, making U.S. approval unlikely

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