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After US Woes, Akebia Celebrates EU Nod For Vafseo

Recommended For Anemia Associated With Kidney Disease

 
• By Kevin Grogan

The US biotech is in the throes of an appeal to the FDA against the rejection of its HIF-PH inhibitor but regulators in the EU have looked more kindly on vadadustat, which will be sold as Vafseo.

Human kidney on scientific background. 3d illustration
• Source: Shutterstock

While Akebia Therapeutics, Inc.'s appeal against the US Food and Drug Administration's rejection last March of vadadustat drags on, the company has received a thumbs-up for the kidney disease therapy in the EU.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion on vadadustat, which will be marketed as Vafseo, for the treatment of symptomatic anemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis

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