Vanda Pharmaceuticals Inc. Announces FDA Grants Landmark Hearing for HETLIOZin Jet Lag Disorder

Vanda Pharmaceuticals Inc. announced that the U.S. 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 March 2, 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 U.S. Court of Appeals for the D.C. 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 criticized 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. HETLIOZ (tasimelteon) is a melatonin-receptor agonist, approved in the United States for the treatment of Non-24-Hour Sleep-Wake Disorder and nighttime sleep disturbances associated with Smith-Magenis Syndrome.