GSK gets Jesduvroq FDA approval for anaemia of chronic kidney disease

GSK has secured the approval of the US Food and Drug Administration (FDA) for the company’s Jesduvroq (daprodustat) for anaemia of chronic kidney disease (CKD) in adults on dialysis.

Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor indicated for the daily once treatment of anaemia due to CKD in adults on dialysis for at least four months.

According to GSK, Jesduvroq tablets are available in 1mg, 2mg, 4mg, 6mg, and 8mg strengths.

Tony Wood — GSK President and Chief Scientific Officer, commenting on Jesduvroq FDA approval, said: “Over the last several decades, there has been little innovation in anaemia of CKD.

“We are proud to have developed Jesduvroq as a new oral treatment where there is a patient desire for more options.”

Jesduvroq FDA approval was backed by the findings of the ASCEND-D phase 3 clinical trial, which demonstrated the efficacy and safety of the HIF-PHI for the treatment of anaemia of CKD in patients on dialysis.

The ASCEND-D clinical trial, which featured 2,964 dialysis patients with anaemia of CKD demonstrated Jesduvroq improved or sustained haemoglobin within target levels (10-11.5 g/dL) for the patients.

Besides, it achieved non-inferiority of major adverse cardiovascular events when compared to an erythropoietin stimulating agent control in the primary safety analysis of the intention-to-treat group.

The European Medicines Agency has accepted marketing authorization application for daprodustat for anaemia of chronic kidney disease (CKD) in adults on dialysis, with a regulatory decision expected in the first half of this year.

In June 2020, Japan’s Ministry of Health, Labour and Welfare approved daprodustat tablets under the brand name Duvroq for the treatment of patients with anaemia of CKD.