GlaxoSmithKline seeking marketing approval for 'daprodustat' in Japan

GlaxoSmithKline announced the submission of a Japanese New Drug Application (JNDA) to the Ministry of Health, Labour and Welfare on Wednesday, seeking marketing approval for ‘daprodustat’.

The FTSE 100 pharmaceuticals giant described daprodustat as an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of patients with renal anaemia due to chronic kidney disease (CKD).

It explained that anaemia is common in patients with CKD, as the kidneys no longer produced adequate amounts of erythropoietin - a hormone involved in prompting the production of red blood cells.

HIF-PHIs were a new class of drug, GSK said, that triggered the body's adaptations to hypoxia and encouraged the bone marrow to make more red blood cells, thus benefiting patients with renal anaemia.

The company said the JNDA for daprodustat was primarily based on positive data from the phase 3 programme conducted in Japan.

It said the studies evaluated daprodustat for the treatment of anaemia in patients across the spectrum of CKD, from stages three to five, and included patients on dialysis and those not on dialysis, regardless of prior anaemia treatment with erythropoiesis-stimulating agents.

Daprodustat is not approved as a treatment for renal anaemia or any other indication anywhere in the world at this stage.

If approved, GSK said daprodustat would be exclusively distributed in Japan by Kyowa Kirin, following the strategic commercialisation deal announced by the two companies in 2018.

Launch activities, including the engagement of healthcare professionals and commercial activities, were expected to be conducted jointly by Kyowa Kirin and GSK.

“Around 3.5 million patients in Japan have anaemia associated with renal disease which can result in weakness and fatigue,” said GlaxoSmithKline’s chief scientific officer and president of research and development, Dr Hal Barron.

“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.”