原始出處紀錄
決策級完整回覆函 (CRL)
Vanda 收到 FDA 關於 HETLIOZ sNDA 用於 Jet Lag Disorder 的決定信
FDA 發出決定信，結論是 tasimelteon 用於 jet lag disorder 的 sNDA 目前形式無法核准，理由是 phase-advance 試驗資料不足以構成有效性的實質證據。Vanda 不同意此結論，並指出該信函是在 D.C. Circuit 發回重審及 2025 年 10 月合作重新審查框架之後發出。
關鍵事實
- 申報時間
- 2026年1月8日 下午12:09
- 事件
- 完整回覆函 (CRL)
- 方向
- 負面
- 來源
- SEC 8-K
- 可信度
- 有出處
來源摘錄
EX-99.1 2 vnda8-k172026exhibit991.htm EX-99.1 Document Exhibit 99.1 Vanda Pharmaceuticals Announces Receipt of FDA Decision Letter on HETLIOZ® Supplemental New Drug Application for Jet Lag Disorder January 8, 2026 WASHINGTON, Jan. 8, 2026 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has received a decision letter from the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) concluding that the supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) for the treatment of jet lag disorder cannot be approved in its current form. This letter stems from CDER's agreed re-review of the jet lag application under the October 1 collaborative framework agreement. The FDA acknowledged positive efficacy from V