VANDA PHARMACEUTICALS ANNOUNCES NOTICE OF OPPORTUNITY FOR AN FDA HEARING ON THE sNDA FOR HETLIOZ® IN JET LAG DISORDER
On September 7, 2022, Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced the opportunity for an FDA hearing regarding its Supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) aimed at treating jet lag disorder. This follows a Complete Response Letter from the FDA received on August 19, 2019. Vanda submitted a hearing request on July 1, 2022, disputing the FDA's findings on the efficacy of their studies. The company remains committed to gaining approval for HETLIOZ® to address an unmet medical need.
- Opportunity for an FDA hearing on the sNDA for HETLIOZ®.
- Vanda submitted four clinical studies supporting HETLIOZ®'s efficacy.
- Received a Complete Response Letter from the FDA on August 19, 2019.
- FDA's characterization of submitted studies was unfavorable, impacting approval chances.
WASHINGTON, Sept. 7, 2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the notice of opportunity for an FDA hearing on Vanda's Supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) to treat jet lag disorder.
On August 19, 2019, Vanda reported that it had received a Complete Response Letter from the FDA for Vanda's sNDA for HETLIOZ® for the treatment of jet lag disorder. On July 1, 2022, Vanda submitted a request for an opportunity for a hearing under section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)) on the question of whether the sNDA is approvable. On August 26, 2022, Vanda received a notice of opportunity for hearing from the FDA. The FDA has indicated that it will publish the notice in a forthcoming issue of the Federal Register, but has not indicated when. Vanda is making the notice available to the public here.
Vanda has provided the FDA with four clinical studies that Vanda believes are adequate and well controlled and provide substantial evidence of efficacy for HETLIOZ® in the treatment of jet lag disorder. Vanda does not agree with the FDA's characterization of these studies and the conclusions reached by the FDA with respect to the sufficiency of its evidence to meet the standard of substantial evidence of efficacy. Vanda welcomes further administrative proceedings and remains committed to obtaining FDA marketing approval for HETLIOZ® for the treatment of jet lag disorder in order to address this significant unmet medical need.
Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on Twitter @vandapharma.
For full U.S. Prescribing Information for HETLIOZ®, including indication and Important Safety Information, visit www.hetlioz.com.
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
Elizabeth Van Every
Head of Corporate Affairs
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.
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