Vanda Announces FDA Grants Landmark Hearing for HETLIOZ® in Jet Lag Disorder, the First Drug Approval Hearing in Over 40 Years

Core Insights - The FDA has granted Vanda Pharmaceuticals a formal evidentiary public hearing regarding the proposed refusal of the supplemental new drug application (sNDA) for HETLIOZ® in treating jet lag disorder, marking the first such hearing in over 40 years [1] - This decision reflects Vanda's persistence over seven years in advocating for the approval of HETLIOZ® and highlights a significant reform step by the FDA towards greater transparency [1] - The hearing follows a favorable ruling from the U.S. Court of Appeals for the D.C. Circuit, which criticized the FDA for not adequately engaging with Vanda's evidence and remanded the matter for resolution [1] Company Overview - Vanda Pharmaceuticals is a global biopharmaceutical company focused on developing innovative therapies to address unmet medical needs [1] - HETLIOZ® (tasimelteon) is currently approved for Non-24-Hour Sleep-Wake Disorder and nighttime sleep disturbances associated with Smith-Magenis syndrome, with the pending sNDA seeking to expand its approval to jet lag disorder [1] Market Context - Jet lag disorder affects millions of travelers globally, including business travelers, athletes, and military personnel, and currently lacks an FDA-approved therapeutic option [1]