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US FDA Spikes Vanda’s Hetlioz For Insomnia, Lack Of Well-Controlled Trial ‘Fatal’

 
• By Sue Sutter

Acting Commissioner Sara Brenner rejected the company’s request for a hearing, saying the lack of an adequate and well-controlled trial showing tasimelteon's effectiveness in treating sleep-onset insomnia is “fatal to the application.”

Gavel and decisionmaker
Acting Commissioner Sara Brenner ended Vanda's bid to add an insomnia indication to the Hetlioz label. (Shutterstock)
Key Takeaways
  • The acting FDA commissioner denied Vanda’s request for a hearing on a new insomnia indication for Hetlioz, citing major evidence gaps, including the lack of an adequate and well-controlled trial demonstrating effectiveness.

Vanda Pharmaceuticals’ Hetlioz (tasimelteon) cannot be approved for a new insomnia indication due to “major...

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