Second approval in China for roxadustat

22 August 2019

FibroGen’s (Nasdaq: FGEN) Beijing-based subsidiary has won Chinese approval for roxadustat, as a treatment for amemia caused by chronic kidney disease (CKD) in non-dialysis-dependent (NDD) patients.

The nod from the National Medical Products Administration (NMPA) makes China the first country in the world to grant approval for roxadustat in this indication.

China has already granted approval for the therapy as a treatment for people with CKD that are on dialysis. FibroGen, together with development partner AstraZeneca (LSE: AZN), plan to launch the product there later in 2019.

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