GSK Applies for Approval of Daprodustat in Japan

GlaxoSmithKline (GSK) has submitted a Japanese New Drug Application (JNDA) for its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), daprodustat, representing the first regulatory filing for the renal anemia therapy.

“Around 3.5 million patients in Japan have anemia associated with renal disease, which can result in weakness and fatigue,” said Hal Barron, chief scientific officer and president R&D, GSK in an Aug. 21, 2019 press release. “We are excited about our first regulatory filing for daprodustat which, if approved, will provide a new and convenient oral treatment option for these patients.”

The regulatory filing has been based on the positive results of three Phase III studies that have all been conducted in Japan. Patients suffering from chronic kidney disease (CKD) from stages three to five were included, whether they were on dialysis or not and regardless of prior treatment for anemia with erythropoiesis-stimulating agents (ESAs).

Daprodustat has not been approved for the treatment of renal anemia, or any other indication, in any country. If it gains approval in Japan, it will be distributed by Kyowa Kirin exclusively as a result of a strategic commercialization deal that was announced in 2018.

Source: GSK