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US FDA Review Of Akebia’s Vafseo Informed By Roxadustat, Daprodustat Safety Concerns

 
• By Sue Sutter

Vadadustat's review overlapped with two other oral HIF-PH class drugs. Safety issues with FibroGen/AstraZeneca’s roxadustat drew attention during vadadustat's first-cycle review, while GSK’s Jesduvroq labeling and postmarketing requirements informed the second-cycle approval.

Drug Review Profile: Vafseo
The FDA's review of Vafseo included a close look at the safety issues flagged for two other drugs. • Source: Shutterstock

The US Food and Drug Administration leveraged safety information from two other same-in-class drugs in its review of Akebia Therapeutics, Inc.’s Vafseo (vadadustat) for chronic kidney disease patients with anemia.

Key Takeaways

  • The FDA’s Vafseo review documents reference the negative safety findings on FibroGen/AstraZeneca’s roxadustat, which was the subject of a CRL in 2021 and has never been approved in the US.

  • Vafseo’s second-cycle review was informed by issues flagged in the assessment of GSK’s Jesduvoq (daprodustat), including heart failure

Vafseo was one of three oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitors that were navigating the FDA

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