GSK announced that the U.S. FDA has approved its once-a-day treatment for anemia due to chronic kidney disease (CKD), specifically for adults who have been receiving dialysis for at least four months.
Daprodustat, branded as Jesduvroq, is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). According to GSK, it is the first innovative medicine for anemia treatment in over 30 years and the only HIF-PHI approved in the U.S. — providing a new oral, convenient option for patients with anemia of CKD on dialysis.
But GSK had set its sights on a broader indication when it submitted its NDA to the agency, hoping to target all patients with anaemia of CKD. However, when the FDA advisory committee met in Oct., they voted 13-3 in favor of the drug for for adult dialysis patients with anaemia of CKD, but 5-11 against approval in adult non-dialysis patients.
Still Jesduvroq has faired better than potential competitors. Last March, the FDA rejected Akebia Therapeutics' anemia pill, vadadustat, over safety concerns. The drug had been the cornerstone of two deals with Japanese drugmaker, Otsuka — both of which were terminated following the agency's rejection
GSK's Jesduvroq will include a boxed warning for increased risk of death, myocardial infarction, stroke, venous thromboembolism and thrombosis of vascular access.
