FDA delays decision on New Drug Application (NDA) for roxadustat for treatment of patients with anaemia and chronic kidney disease

FDA is to convene expert panel to review NDA for this oral, first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor designed to improve iron absorption & mobilisation. Licensing application was filed last year in EU, based on phase III program in >9000 patients.

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Biospace Inc.