FDAnews
www.fdanews.com/articles/205266-gsks-treatment-for-anemia-due-to-ckd-effective-in-late-stage-study

GSK’s Treatment for Anemia Due to CKD Effective in Late-Stage Study

November 10, 2021

GlaxoSmithKline’s (GSK) daprodustat increased or maintained hemoglobin levels in patients with anemia due to chronic kidney disease (CKD) across five phase 3 studies, says a new analysis.

The trials, which enrolled more than 8,000 patients treated for up to 4.26 years, demonstrated that daprodustat was well-tolerated in both dialysis and nondialysis patients, and the positive hemoglobin results are in line with topline findings released in July, showing that daprodustat met its primary efficacy endpoints.

Daprodustat, which belongs to a class of drugs called hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs), works by blocking an enzyme that regulates the biosynthesis of erythropoietin and maintains iron levels in the body.

And GSK noted the findings indicate that daprodustat is the first oral HIF-PHI to show both positive efficacy and no increased cardiovascular risk, when compared against an erythropoietin stimulating agent, a standard treatment option.

View today's stories