Could the third time be the charm for an oral HIF-PH inhibitor in the U.S.? GlaxoSmithKline certainly hopes so, with its potential first-in-class medicine now officially up for a decision at the FDA by early next year.
The FDA has accepted GSK’s application for daprodustat as an oral therapy for patients with anemia of chronic kidney disease (CKD), the company said Tuesday. The FDA plans to deliver its daprodustat verdict by Feb. 1, 2023, GSK said.
The move follows high-profile FDA rejections of two other HIF-PHI class members in anemia. Those are Akebia Therapeutics and Otsuka’s vadadustat, swatted down in March, and AstraZeneca and Fibrogen’s roxadustat, which was rebuffed back in August.
Safety concerns weighed heavily on both of the regulator’s decisions.
Daprodustat’s application, meanwhile, leverages data from GSK’s Ascend phase 3 clinical program, which covered five pivotal trials weighing the safety and efficacy of the med in anemia patients “across the spectrum of CKD,” GSK said. The company also published data from key cardiovascular outcomes trials in the New England Journal of Medicine in November. Those heart studies looked at both CKD patients on dialysis and those who were not.
Both cardiovascular outcomes trials, dubbed Ascend-ND and Ascend-D, met their primary safety and efficacy endpoints, GSK added.
Overall, daprodustat’s studies showed the drug helped improve or maintain target hemoglobin levels without an increase of major cardiovascular events versus standard of care—an erythropoietin stimulating agent (ESA)—across both dialysis and non-dialysis patients, GSK said.