Vafseo Chronology: Complete Response Letter, Dispute Resolution And A Second-Cycle Approval

 
• By Sue Sutter

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.

Drug Review Profile: Vafseo Chronology
Valadustat needed almost 15 years for to move from IND submission to NDA approval. • Source: Shutterstock

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