GSK submits first regulatory application for daprodustat in Japan
Singapore, Aug. 23 -- GSK has announced the submission of a Japanese New Drug Application (JNDA) to the Ministry of Health, Labour and Welfare seeking marketing approval for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of patients with renal anaemia due to chronic kidney disease (CKD).
Dr Hal Barron, Chief Scientific Officer and President R&D, GSK said, "Around 3.5 million patients in Japan have anaemia associated with renal disease which can result in weakness and fatigue. 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."
Anaemia is common in patients with CKD because...
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