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

Core Points - Vanda Pharmaceuticals Inc. achieved a significant legal victory against the FDA regarding the approval of HETLIOZ® (tasimelteon) for treating jet lag disorder [1][4] - The U.S. Court of Appeals for the D.C. Circuit ruled that the FDA must engage meaningfully with the evidence presented by drug innovators like Vanda [4][6] - The court's decision mandates that the FDA either approve the supplemental New Drug Application (sNDA) or conduct a hearing on the matter [4][6] Company Summary - Vanda submitted its sNDA in October 2018, but the FDA delayed the resolution, leading to a federal court ruling that the FDA violated the Food, Drug, and Cosmetic Act [2][3] - The court found that Vanda provided substantial evidence of tasimelteon's efficacy in improving sleep disturbances, with trials showing statistically significant improvements [4][5] - Vanda has invested over a decade in clinical studies to develop HETLIOZ®, which has the potential to significantly benefit individuals suffering from jet lag [5][6] Industry Impact - The court's ruling alters the relationship between the FDA and pharmaceutical companies, emphasizing the need for the FDA to fairly evaluate scientific evidence [6][7] - This decision may encourage other drug manufacturers to challenge FDA decisions that they believe are unjust, potentially leading to more innovative therapeutics reaching the market [7]