Shots:

• The NDA submission is based on three P-III studies conducted in Japan i.e- 52-wks. study assessing daprodustat vs darbepoetin alpha in 271 hemodialysis patients prior using erythropoiesis-stimulating agents (ESAs). 52wks. study evaluating daprodustat vs epoetin beta pegol in 299 patients with stage 3-5 CKD not on dialysis- with/out prior use of ESAs and 24wks. study evaluating daprodustat in 28 hemodialysis patients who were not receiving ESAs
• Additionally- daprodustat is been evaluated in an ongoing P-III global clinical program which includes ASCEND-D & ASCEND-ND study in dialysis & non- dialysis-dependent patients with anemia associated with CKD switching from an ESA & switching from or naïve to an ESA respectively
• Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor- leading to transcription of erythropoietin and other genes involved in RBC production and iron metabolism. Post-approval- Kyowa Kirin will exclusively distribute daprodustat in Japan following 2018 deal with GSK

Click here to­ read full press release/ article

Ref: GSK | Image: GSK