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One To Watch: Ruling On AZ’s First-In-Class Anemia Drug Roxadustat Expected Shortly

Label Warning Will Be Key

 
• By Andrew McConaghie

AstraZeneca is in pole position to open up the HIF-PH inhibitor market – but GSK has a rival in the wings.

Blood transfusion
Roxadustat has been developed for patients with chronic kidney disease-induced anemia, regardless of whether they dependent on blood transfusions or not.

A decision from the US Food and Drug Administration on AstraZeneca’s roxadustat for patients with anemia of chronic kidney disease (CKD) is expected shortly, the ruling possibly coming well ahead of its PDUFA deadline of 20 March.

Industry analysts are predicting peak annual sales of $2bn or more for roxadustat, but its success will hinge on whether...

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