Federal Appeals Court Overturns FDA Rejection of Vanda’s Hetlioz for Jet Lag Disorder

A federal appeals court has overturned the FDA's prior refusal to approve Vanda Pharmaceuticals' Hetlioz (tasimelteon) for the treatment of jet lag disorder135.

The court found that the FDA failed to properly consider the specific and evidence-based data Vanda presented, terming the agency’s review as 'cursory'3.

The case was remanded to the FDA, which must now either approve Hetlioz for jet lag disorder or grant Vanda a hearing on its supplemental New Drug Application (sNDA)14.

Vanda originally submitted the sNDA in October 2018, but the FDA delayed and ultimately issued a Complete Response Letter (CRL) in 2019, citing concerns over clinical significance, despite clinical trials showing statistically significant improvements in sleep duration52.

This ruling establishes a legal precedent that the FDA must meaningfully engage with scientific evidence submitted by drug developers, potentially altering future regulatory interactions for all pharmaceutical companies32.

The path forward for Hetlioz requires either FDA approval or a formal hearing process to review the evidence further124.

Sources:

1. 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

2. https://www.stocktitan.net/news/VNDA/in-a-major-win-for-vanda-a-federal-appeals-court-overturns-fda-s-9htybccpru2a.html

3. https://www.thepharmaletter.com/pharmaceutical/vanda-wins-appeals-court-fight-over-fda-jet-lag-ruling

4. https://www.ainvest.com/news/vanda-pharmaceuticals-secures-victory-fda-jet-lag-disorder-treatment-dispute-2508/

5. https://www.pharmexec.com/view/court-overturns-fda-decision-reject-vanda-pharmaceutical-jet-lag-disorder-treatment