Vanda Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has granted the company’s request for a formal evidentiary public hearing to review the Center for Drug Evaluation and Research’s (CDER) proposal to refuse approval of Vanda’s supplemental new drug application (sNDA) for Hetlioz® (tasimelteon) in the treatment of jet lag disorder.
The FDA confirmed the decision to grant a hearing in a letter from the Office of the Commissioner dated 2 March 2026. The hearing will proceed under 21 CFR Part 12, after which the presiding officer will issue an initial decision pursuant to 21 CFR § 12.120.
Granting a formal evidentiary public hearing in response to a proposed refusal to approve a drug application is a rare and highly significant regulatory step.
Publicly available records and historical accounts indicate that the FDA has not granted such a hearing under 21 CFR Part 12 in the context of drug approvals for decades—potentially over 40 years — underscoring the gravity of the legal and scientific issues raised by Vanda.
This development follows Vanda’s prior success in Vanda Pharmaceuticals Inc. v. FDA, case no. 24-1049, before the US Court of Appeals for the DC Circuit.
In August 2025, the court set aside the FDA’s earlier refusal to approve Hetlioz® for jet lag disorder.
The ruling held that the FDA unlawfully failed to adequately engage with Vanda’s evidence — despite statistically significant results from clinical trials—and criticised the agency’s cursory treatment of expert, evidence-based submissions.
The court remanded the matter, directing the FDA to finally resolve Vanda’s sNDA or commence a hearing.
Hetlioz® is currently approved in the United States for non-24-hour sleep-wake disorder and nighttime sleep disturbances associated with Smith-Magenis syndrome.
The pending sNDA seeks to expand approval to treat jet lag disorder, a condition that affects millions of travelers worldwide — including business travelers, athletes, and rapidly deployed troops — for which there is currently no FDA-approved therapeutic.
