FDA Accepts Application for GSK’s Chronic Kidney Disease Drug
Prashant Chauhan
FDA accepted the New Drug Application (NDA) for GSK’s daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to treat patients with anemia of chronic kidney disease (CKD).
The agency based its decision on positive results from the ASCEND Phase 3 clinical trial program, which included five pivotal trials assessing the efficacy and safety of daprodustat in 8,000 non-dialysis and dialysis patients for up to 4.26 years. The ASCEND-ND trial enrolled 3,872 non-dialysis dependent patients who were either switched from the standard of care therapy or not currently receiving erythropoietin stimulating agent (ESA) therapy to receive daprodustat or ESA control.
And the ASCEND-D trial enrolled nearly 2,964 dialysis patients with anemia of CDK who were switched to receive daprodustat or ESA control from a standard of care ESA therapy. Overall, researchers found that the drug improved or maintained hemoglobin (Hb) within the target level without increased major adverse cardiovascular across both patient settings. Notably, both trials achieved non-inferiority.
Daprodustat is currently approved in Japan as Duvroq for patients with renal anemia. And the European Medicines Agency (EMA) validated the marketing authorization application (MMA) for daprodustat, which is currently under review. Additional regulatory filings are anticipated to continue through 2022. Over 700 million people suffer from CKD globally. And about one in seven of these patients suffer from anemia.
In May 2021, FDA approved AstraZeneca’s Farxiga oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with CKD.
FDA based its decision on a multicenter, double-blind study, which found that Farxiga and the standard-of-care treatment reduced the relative risk of worsening renal function or renal death by 39% compared to placebo in patients with CKD stages two through four. The agency initially approved Farxiga in 2014 to improve glycemic control in adults with type 2 diabetes.
