AstraZeneca and FibroGen’s Roxadustat Receive NMPA’s Approval for the Treatment of Anemia in Non-Dialysis-Dependent Patients with Chronic Kidney Disease in China

Shots:

• The NMPA’s approval is based on P-III study result assessing Roxadustat vs PBO in non-dialysis-dependent (NDD) patients with CKD demonstrating improvement in hemoglobin levels with a mean change of (1.9 g/dL vs -0.4 g/dL) on 7-9wks. treatment
• In 2013, AstraZeneca and FibroGen collaborated for the development & commercialization of Roxadustat in China. The NMPA’s approval follows the approval of Roxadustat for anemia in dialysis-dependent CKD patients in Dec’2018 in China
• Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor, promoting erythropoiesis and is approved in China making it first country to approve Roxadustat for all CKD patients with anemia with its expected launch in China in H2’19

Click here to­ read full press release/ article | Ref: AstraZeneca | Image: Twitter