GSK Reports Submission of NDA to MHLW for Daprodustat to Treat Patients with Renal Anaemia due to Chronic Kidney Disease in Japan

 GSK Reports Submission of NDA to MHLW for Daprodustat to Treat Patients with Renal Anaemia due to Chronic Kidney Disease in Japan

GSK Reports Submission of NDA to MHLW for Daprodustat to Treat Patients with Renal Anaemia due to Chronic Kidney Disease in Japan

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: South China Morning Post

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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