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.
- The agency refused to approve the sNDA, which was the subject of a March 2024 complete response letter.
- Vanda, which has a history of challenging FDA decisions, said the hearing denial is another example of the agency avoiding the public scrutiny and input of independent experts.
Vanda Pharmaceuticals’ Hetlioz (tasimelteon) cannot be approved for a new insomnia indication due to “major gaps in the evidence,” US Food and Drug Administration Acting...
Brenner agreed with the Center for Drug Evaluation and Research’s refusal to approve the tasimelteon supplemental application for treatment of insomnia characterized by difficulties with sleep initiation.
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