REUTERS/Dado Ruvic/Illustration/Oct 26 (Reuters) - GSK Plc (GSK.L) came closer to securing its first drug approval since its consumer health spin-off in July as an expert panel of the U.S. health regulator backed an approval for its drug to treat anemia in some patients with chronic kidney disease (CKD).
The advisers to the Food and Drug Administration on Wednesday voted 13-3 in favor of the oral drug for patients on dialysis, although GSK was expecting approval for a broader CKD population.
The panel, hesitant about backing the drug for patients not on dialysis, voted 11-5 against it for that group, citing increased safety risks such as heart failure.
read moreGSK's drug, daprodustat, is the first from the HIF-PH inhibitor class to win U.S. FDA panel's endorsement.
The FDA, which usually follows the recommendations of its expert panel, is expected to make its final decision on the drug by Feb. 1.