Vanda Pharmaceuticals received a decision letter from the FDA regarding the supplemental New Drug Application for HETLIOZ® for jet lag disorder.
The FDA concluded that the current form of the application cannot be approved due to lack of substantial evidence of effectiveness for jet lag disorder.
Vanda disagrees with the interpretation and believes that the submitted data meets the standard for effectiveness on clinically relevant endpoints.
FDA Decision
The FDA decision letter states the supplemental New Drug Application for HETLIOZ® for jet lag disorder cannot be approved in its current form.
Vanda's Disagreement
Vanda disagrees with the FDA's conclusion and maintains that their submitted dataset meets the standard for effectiveness on clinically relevant endpoints.
Collaborative Framework Agreement
Vanda and FDA had entered a collaborative framework agreement for an expedited re-review of the application.
- The FDA decision raises uncertainties about the approval timeline for HETLIOZ® in treating jet lag disorder.
- Vanda's efforts to work constructively with the FDA and pursue appropriate avenues for approval may affect the future availability of the therapy for travelers.
Vanda remains committed to working with the FDA to advance the approval of HETLIOZ® for jet lag disorder and make this therapy available to patients in need. The company's determination to address the FDA's concerns reflects their dedication to providing innovative therapies for unmet medical needs.