Akebia’s Vafseo: Japanese Postmarketing Data, Narrowed Indication Eased Liver Toxicity Worries

 
• By Sue Sutter

The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.

Drug Review Profile: Vafseo
The FDA approved Akebia's Vafseo for treatment of anemia in chronic kidney disease patients on dialysis. • Source: Shutterstock

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