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Court Overturns FDA’s Decision to Reject Vanda Pharmaceutical’s Jet Lag Disorder Treatment
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Key Takeaways
- Vanda Pharmaceuticals won a legal battle as a federal court overturned the FDA's rejection of Hetlioz for jet lag disorder, highlighting the court's support for Vanda's evidence.
- The court criticized the FDA's cursory handling of Vanda's evidence, remanding the case back to the FDA for further action, potentially leading to approval or a hearing.
The latest decision will give Vanda the opportunity to have a hearing with FDA over the sNDA’s status.
Vanda says FDA never held a hearing with it in regards to a CRL and subsequent rejection of a jet leg disorder treatment.
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Vanda Pharmaceuticals is celebrating a legal win in its longstanding feud with FDA.
The pharmaceutical company announced that that federal appeals court overturned FDA’s decision to deny approval of Hetlioz for the treatment of jet lag disorder (JLD).1 This is the latest development in a year’s long struggle to get the treatment approved for the new indication. Vanda first submitted the drug’s supplemental New Drug Application (sNDA) back in October 2018.
What does the latest court ruling mean for Vanda Pharmaceuticals?
However, in August 2019, FDA issued a CRL to Vanda in response to the application.2 At the time, Vanda said that FDA described the measures demonstrating the drug’s ability to improve sleep were “of unclear clinical significance.” According to Vanda, patients taking the medication during a transatlantic trip slept nearly three hours longer than those on the trip who did not take the medication.
At the time, Vanda said it was “perplexed” by the decision and cited the “millions of travelers who experience JLD ever year.” The CRL reportedly detailed other issues with the sNDA, but Vanda did not provide specific details at the time about those issues.
In response to the CRL, Vanda president and CEO Mihael H. Polymeropoulos, MD, said, “We are deeply disappointed to have not received approval at this time, given our previous discussions with the FDA on this program. Vanda remains committed to obtaining FDA marketing approval for tasimelteon in Jet Lag Disorder in order to address this significant unmet medical need."
Vanda responded by requesting a hearing on the CRL. As of this date, that hearing has still not happened. Instead, FDA rejected the sNDA in 2024, prompting Vanda to file a lawsuit, asking the court to overturn the decision and force FDA to hold a hearing with Vanda over the contents of the CRL.
In the latest update, the court sided with Vanda and set aside FDA’s rejection. In a statement, Vanda says that the court found Vanda’s views were” specific, reasoned, and rooted in evidence” and that FDA’s treatment of said evidence was “cursory.”
In its statement, a spokesperson for Vanda says, “This decision significantly alters the relationship between the FDA and the parties it regulates. The Court's holding establishes that the FDA must meaningfully engage with the evidence presented by drug innovators, and the FDA may not shield its decisions via a plea for deference. The Court has remanded the case back to the FDA, where Vanda anticipates the FDA will either approve the sNDA or Vanda will receive a hearing.”
This is not the only FDA decision Vanda has publicly taken issue with. In April, the company criticized the agency for delaying a hearing on the approvability of tradipitant for gastroparesis.2 According to Vanda, FDA cited a significant reduction in staffing as its reason for delaying the hearing. However, Vanda argues that the cuts were said to not include scientists or reviewers.
At the time, Vanda issued a statement, in which it said, “It is unfair for CDER and its lawyers to blame the recent reductions in force for their habitual institutional delays on hearing requests. These statements also conceal the extraordinary fact that FDA has denied every hearing request on new drug approvability for at least the past decade.”
In the same statement, Polymeropoulos also said, “Vanda has fought for 'transparency and common sense' for years because rational innovation can only thrive in a democracy and not in a bureaucracy. It is time for FDA and DOJ to stop fighting innovators like Vanda, focus on what is broken and listen to ideas of how it can be fixed, and usher in a new era of rational and transparent decision making.”
Sources
- In a Major Win for Vanda, a Federal Appeals Court Overturns FDA's Order Denying Approval of Hetlioz for the Treatment of Jet Lag Disorder. Vanda Pharmaceuticals. August 18, 2025. https://www.prnewswire.com/news-releases/in-a-major-win-for-vanda-a-federal-appeals-court-overturns-fdas-order-denying-approval-of-hetlioz-for-the-treatment-of-jet-lag-disorder-302531842.html
- Vanda Pharmaceuticals FDA Update for HETLIOZ® in the Treatment of Jet Lag Disorder. Vanda Pharmaceuticals. August 19, 2019. Accessed August 18, 2025. https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-fda-update-for-hetlioz-in-the-treatment-of-jet-lag-disorder-300903345.html
- FDA Bureaucrats Unlawfully Delay Hearing on Vanda Drug and Falsely Blame Commissioner Makary and the reductions in force at FDA. Vanda Pharmaceuticals. April 23, 2025. Accessed August 18, 2025. https://www.prnewswire.com/news-releases/fda-bureaucrats-unlawfully-delay-hearing-on-vanda-drug-and-falsely-blame-commissioner-makary-and-the-reductions-in-force-at-fda-302436404.html
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