AstraZeneca Reports Pooled Cardiovascular Safety and Efficacy Analyses of Roxadustat in P-III Program for CKD Patients with Anaemia

The P-III program involves assessing of Roxadustat vs PBO and epoetin alfa in 9,000+ NDD and DD & ID patients in multiple studies conducted by AstraZeneca, FibroGen and Astellas together globally respectively.

Results: The risk of MACE, MACE+ and all-cause mortality & Hb level (1.85 g/dL vs 0.13 g/dL) in NDD patients was comparable to PBO, showed 30% lower risk of MACE and 34% lower risk of MACE+ with a trend towards lower all-cause mortality in ID patients, no increased risk of MACE and all-cause mortality and a lower risk of MACE+, Hb level (1.22 g/dL vs 0.99 g/dL) in DD patients

Roxadustat is a first-in-class, hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) being evaluated for the treatment of anaemia in CKD. The results from pooled analysis served as a basis for its anticipated regulatory submission in the US.

November 11, 2019

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