Zydus files for Indian approval of CKD candidate desidustat

23 November 2021

India-based Zydus Cadila, a part of Cadila Healthcare (NSE: CADILAHC), has submitted the New Drug Application (NDA) to the Drug Controller General of India for desidustat, an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for treatment of anemia in patients with chronic kidney disease (CKD) who are on or not on dialysis.

Just last Saturday, Zydus Cadila announced that it had received final approval from the US Food and Drug Administration to market decitabine for injection in the USA to treat myelodysplastic syndromes, certain types of blood or bone marrow cancer.

The NDA for desidustat is based on positive data from the DREAM-ND and DREAM-D Phase III trials in patients with CKD regardless of dialysis.

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