Vanda Wins Appeal to Overturn FDA Denial for Hetlioz

This victory for Vanda (case no. 24-1049) culminates a long-running dispute that began in October 2018 when the company submitted its supplemental New Drug Application (sNDA) to expand the use of HETLIOZ®—already approved for other sleep disorders—to treat jet lag.

The legal battle escalated after a federal district court found that the FDA had “violated” the Food, Drug, and Cosmetic Act by delaying a resolution on Vanda’s application. Ordered to either resolve the sNDA or hold a hearing, the FDA chose to grant itself summary judgment and refuse approval, a decision that a federal court has now set aside.

The D.C. Circuit Court of Appeals’ ruling was a decisive rebuke of the FDA’s process. The court found the agency’s “treatment of Vanda’s evidence is cursory,” in stark contrast to Vanda’s “specific, reasoned, and rooted in evidence” expert views. The court highlighted that Vanda had presented “meaningful evidence of tasimelteon’s efficacy in improving sleep disturbance,” with each of its trials showing “statistically significant improvement on the primary endpoint measured.”

This decision establishes a critical legal precedent that will likely alter the relationship between the FDA and the companies it regulates. The court’s holding makes it clear that the FDA cannot simply plead for deference but must genuinely and substantively engage with the scientific evidence presented by drug innovators. For too long, drug manufacturers have not exercised their rights to lawful treatment by the FDA, and this ruling demonstrates how courts can intervene to set aside government actions that impede innovation and deprive the public of important new treatments.

For the millions of people who suffer from jet lag, this is a major development. Vanda has invested more than a decade in innovative clinical studies, with results published in peer-reviewed journals, to develop HETLIOZ® as a potential therapeutic solution. The company believes the drug has the potential to fundamentally reset circadian rhythms for travelers—from business travelers and tourists to athletes and military personnel—providing them with a meaningful treatment option for a condition that has no FDA-approved therapy.

The case has been remanded back to the FDA, where Vanda anticipates a new, fair evaluation of its sNDA. The company believes the FDA will now either approve the application or, as the court’s decision suggests, grant a full hearing on the matter.