A court victory forces the Food and Drug Administration to re-examine rejected application for expanded indication.

In a significant legal victory for Vanda Pharmaceuticals, the US Court of Appeals for the DC Circuit has ordered the US Food and Drug Administration (FDA) to reconsider its rejection of an expanded indication for HETLIOZ (tasimelteon), potentially opening the door for the first FDA-approved treatment specifically targeting jet lag disorder.

Years of Regulatory Disputes

The controversy began in 2018 when Vanda submitted a supplemental New Drug Application (sNDA) seeking to expand HETLIOZ’s approved uses beyond rare sleep disorders to include jet lag treatment. Currently, the drug is only approved for Non-24-Hour Sleep-Wake Disorder and Smith-Magenis Syndrome-related sleep disturbance.

The FDA’s initial response in 2019 was lukewarm at best. In a Complete Response Letter, the agency dismissed Vanda’s clinical data showing improved sleep outcomes following transatlantic travel as being “of unclear clinical significance.” This rejection set off a protracted legal battle that would span multiple years and federal courts.

When the FDA substantially delayed addressing Vanda’s request for a hearing on the application, the pharmaceutical company took the unusual step of filing suit in federal district court. The court’s ruling was unambiguous: the FDA had violate” requirements under the Food, Drug, and Cosmetic Act by failing to properly process Vanda’s application.

Rather than comply with the court’s order to either resolve the application or commence a hearing, the FDA chose a different path. The agency granted summary judgment to itself and issued an outright refusal to approve the sNDA, effectively attempting to sidestep the judicial mandate.

This move prompted Vanda to escalate the matter to the U.S. Court of Appeals for the D.C. Circuit, which also ruled in Vanda’s favor.

Appeals Court Delivers Rebuke

In setting aside the agency’s action, the three-judge appellate panel delivered pointed criticism of how the FDA handled Vanda’s evidence.

The court found that Vanda had provided expert opinions that were “specific, reasoned, and rooted in evidence,” while characterizing the FDA’s evaluation as “cursory.” Most significantly, the judges noted that Vanda had “clearly offered meaningful evidence of tasimelteon’s efficacy in improving sleep disturbance” and that each clinical trial “showed statistically significant improvement on the primary endpoint measured.”

What’s Next for HETLIOZ

With the case now remanded back to the FDA, Vanda anticipates one of two outcomes: either the agency will approve the sNDA for jet lag treatment, or Vanda will finally receive the formal hearing it requested years ago.

According to Vanda, HETLIOZ has the potential to fundamentally change the landscape of circadian resetting during transmeridian global travel.

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