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Vanda Pharmaceuticals collaborates with the FDA to expedite reviews for Hetlioz and Tradipitant, aiming to resolve ongoing disputes and approvals.
The agreement aims to solve the longstanding dispute with the agency regarding the approval of Hetlioz to treat jet lag disorder.
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Vanda Pharmaceuticals announced it has agreed on a collaborative framework with FDA, aiming to resolve certain disputes regarding Hetlioz. The collaborative agreement follows a federal court’s decision to overturn FDA’s order denying Hetlioz’s approval as a treatment for jet lag disorder.2
Per the terms of collaborative framework agreement, FDA will conduct an expedited re-review on the partial clinical hold that’s preventing long-term clinical studies of Tradipitantas a treatment for motion sickness by late November of this year.1 FDA is expected to continue its review of the New Drug Application (NDA) from Vanda for this specific indication, and have set the Prescription Drug User Fee Act (PDUFA) target action date for December 30, 2025.1
Additionally, FDA will conduct an expedited re-review of Vanda's supplemental New Drug Application (sNDA) for Hetlioz for the treatment of jet lag disorder by the target action date of January 7, 2026, while also including consideration for alternative or niche indications focusing on the sleep-related aspects of jet lag disorder.1 Vanda and FDA are expected to temporarily pause the Part 12 proceedings from D.C. Circuit's recent decision in Vanda Pharmaceuticals v. FDA, No. 24-1049.1 Along with pausing Part 12 proceedings, FDA and Vanda both aim to reach a temporary pause in ongoing administrative proceedings before FDA Commissioner Marty Makary, for Vanda's NDA for Tradipitant for indication in gastroparesis, with a target date of January 7, 2026.The last pause mentioned in the agreement, aims to halt Vanda's lawsuit challenging FDA's practice in deciding new drug applications taking up to 12 months, rather than the statutory 180 days.1
Along with the pauses in multiple Vanda v. FDA court cases, Vanda announced it is dismissing its lawsuit against FDA's partial clinical hold preventing long term studies of Tradipitant for the treatment of motion sickness. Vanda is also expected to dismiss its lawsuit regarding Vanda's request to provide information to prescribers and patients regarding the efficacy of Hetlioz in Jet Lag Disorder.1
The most recent dispute between Vanda and FDA came back in August of this year, which resulted in a federal court overturning FDA’s decision to reject Hetlioz as a jet lag disorder treatment. Vanda submitted its sNDA back in October 2018, aiming to market Hetlioz as a treatment for Jet Lag Disorder.1 After FDA substantially delayed resolving Vanda's request for a hearing, a federal district court found that the FDA "violated" the requirements of the Food, Drug, and Cosmetic Act, and resulted in the court requiring FDA to finally resolve Vanda's sNDA, or commence a hearing.1 FDA decided not to commence a hearing,instead electing to grant a summary judgment to itself and issued an order refusing to approve the sNDA. FDA aimed to disregard the factual evidence Vanda presented to it, and resulted in Vanda fileing a petition for review with the U.S. Court of Appeals for the D.C. Circuit.1 The court set aside the FDA's action and explained that Vanda provided expert views that were "specific, reasoned, and rooted in evidence" and that FDA's "treatment of Vanda's evidence is cursory," resulting in Vanda winning the case.
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