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Veozah Warning On Liver Injury Could Present New Commercial Roadblock

 
• By Jessica Merrill

The US FDA updated labeling for Astellas’ drug for hot flashes after a postmarketing report of a single patient with signs and symptoms of liver injury taking the medicine. 

caution
FDA warned patients about a risk of liver injury with Veozah • Source: Shutterstock

Astellas Pharma, Inc.’s Veozah (fezolinetant) for hot flashes caused by menopause got off to a slow commercial start, despite a high unmet need for nonhormonal treatment options for menopausal women. A new updated warning from the US Food and Drug Administration on a rare but serious risk of liver injury could further complicate the commercial ramp.

Key Takeaways
  • An updated warning on risk of liver injury could pose commercial headwinds for Astellas’s Veozah for hot flashes.
  • The FDA updated the warnings section of Veozah’s prescribing information based on a postmarketing report of a woman with symptoms of liver injury after taking Veozah for around 40 days

The updated warning may put Veozah at a disadvantage to Bayer AG’s rival drug elinzanetant, which could potentially launch in 2025, if the rival product is approved without a similar warning. No hepatotoxicity has been observed in Bayer’s Phase III OASIS program testing elinzanetant, an NK-1,3 receptor antagonist

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