ALPMY - Here's What Recent News From the FDA Means for AstraZeneca
Last month, the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) of the U.S. Food and Drug Administration (FDA) denied AstraZeneca (NASDAQ: AZN) and FibroGen 's (NASDAQ: FGEN) drug roxadustat for the treatment of anemia in patients with chronic kidney disease (CKD).
This was in both non-dialysis-dependent (NDD) patients (by a 13-to-1 vote) and dialysis-dependent (DD) patients (a 12-to-2 vote).
AstraZeneca and FibroGen are collaborating to develop and commercialize roxadustat for the treatment of anemia related to CKD in areas including the U.S., Australia and New Zealand, China, and Southeast Asia. Meanwhile, FibroGen and Astellas Pharma (OTC: ALPMY) are developing and commercializing roxadustat for the treatment of CKD-related anemia in Japan, Europe, the Middle East, and South Africa.
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Here's What Recent News From the FDA Means for AstraZeneca