Adcomm offers mixed vote, recommends GSK's kidney disease drug in just one patient population
A day after the FDA raised safety concerns regarding a kidney disease candidate from GSK, the company did not end up with all green lights from an adcomm.
The FDA’s Cardiovascular and Renal Drugs Advisory Committee met over daprodustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor once lauded by ex-R&D head Hal Barron as a top drug for anemia in patients with chronic kidney disease in the drugmaker’s late-stage pipeline. The FDA, as of Tuesday, raised some questions about if the benefits were worth it, given some of the potential risks. Those risks, according to the agency, would have included heart failure and gastric erosions, plus heart attacks and risks for strokes in a more specific subgroup of patients.
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