Vanda Pharmaceuticals Inc. announced on August 18, 2025, a landmark victory against the U.S. Food and Drug Administration (FDA) in its dispute over the approvability of HETLIOZ (tasimelteon) for jet lag disorder. The U.S. Court of Appeals for the D.C. Circuit set aside the FDA's order denying approval of Vanda's supplemental New Drug Application (sNDA).
The Court found that Vanda had provided expert views that were "specific, reasoned, and rooted in evidence," and criticized the FDA's "cursory" treatment of Vanda's evidence. Specifically, the Court noted that Vanda "clearly offered meaningful evidence of tasimelteon's efficacy in improving sleep disturbance" and that each of its trials showed statistically significant improvement on the primary endpoint.
This decision significantly alters the relationship between the FDA and regulated parties, establishing that the FDA must meaningfully engage with evidence presented by drug innovators. The case has been remanded back to the FDA, where Vanda anticipates either approval of the sNDA or a hearing, potentially making HETLIOZ available for jet lag sufferers after more than a decade of development.
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