The US regulatory history of Akebia Therapeutics, Inc.’s Vafseo (vadadustat) featured a complete response letter, a denied formal dispute resolution request, and a race with two other drugs in the same novel class that were pursuing a broad indication for treatment of anemia in chronic kidney disease patients.
Vafseo Chronology: Complete Response Letter, Dispute Resolution And A Second-Cycle Approval
The Pink Sheet’s Drug Review Profile looks at the timeline behind the development and US FDA approval of Akebia’s Vafseo, a treatment for anemia in chronic kidney disease patients on dialysis.
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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.
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