GlaxoSmithKline's Anemia Candidate Shows Promise In Late-Stage Studies

GlaxoSmithKline Plc GSK said its anemia drug for patients with chronic kidney disease succeeded in five late-stage trials.
The drug, daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, works by copying the body's response to hypoxia (low oxygen levels) and boosts the production of red blood cells by mimicking the body's response to high altitude.
GSK said results from Phase 3 ASCEND program showed the drug improved hemoglobin levels in patients who had not received any standard care and helped maintain the levels in those who received erythropoietin stimulating agent (ESA).
Daprodustat was also well-tolerated in both dialysis and non-dialysis patients.
In addition, the key cardiovascular outcomes studies for non-dialysis and dialysis patients demonstrated that daprodustat was non-inferior compared to an ESA in the risk of Major Adverse Cardiovascular Events, the co-primary endpoint of both studies.
The news comes just a few hours after GSK's rival drug roxadustat got a thumbs down from the FDA.
Developed by AstraZeneca plc AZN and Fibrogen Inc FGEN, it works just like GSK's treatment.
GSK's daprodustat is currently approved only in Japan for use in patients with renal anemia. Roxadustat is approved in China.
Price Action: GSK shares are up 0.13% at $39.66 during the premarket session on the last check Friday.