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.”
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...