WASHINGTON, Feb. 5, 2024
/PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA)
today announced that on February 4,
2024, it received a notification from the U.S. Food and Drug
Administration (FDA) stating that as part of its ongoing review of
Vanda's supplemental New Drug Application (sNDA) for
HETLIOZ® (tasimelteon) in the treatment of insomnia
characterized by difficulties with sleep initiation, the FDA has
identified deficiencies that preclude discussion of labeling and
postmarketing requirements/commitments at this time. No
deficiencies were disclosed by the FDA in the notification, and the
FDA stated that the notification does not reflect a final decision
on the information under review. In a letter to Vanda dated
July 17, 2023, the FDA had assigned a
Prescription Drug User Fee Act target date of March 4, 2024 for the completion of its review of
the sNDA.
Vanda has extensively studied the efficacy of
HETLIOZ® in the treatment of insomnia characterized by
difficulties with sleep initiation. A Phase III, multi-center,
placebo-controlled, 4-week trial evaluated patients with chronic
primary insomnia. Two transient insomnia studies induced by phase
advance of the sleep-wake cycle were also conducted with five-hour
and eight-hour phase advance, which showed a significant effect the
first night in improving sleep parameters.
Vanda believes that the timing of the FDA's communication is
part of an ongoing violation of the Federal Food Drug, and Cosmetic
Act (FDCA). The FDCA requires the FDA to either approve a new drug
application or provide an opportunity for a hearing within 180 days
after the filing of an application.1 Because Vanda
submitted the sNDA on May 4, 2023,
the FDA's deadline under the FDCA was October 31. 2023. The FDA has not complied with
the statute and has not timely approved the application or provided
an opportunity for a hearing within the statutorily prescribed
timeframe. Vanda is also challenging the FDA's approvals of several
generic versions of HETLIOZ®, which have been marketed
since 2023.
Vanda remains committed to its efforts to hold the FDA
accountable to the law, ensuring predictable regulatory
conduct.
References
- 21 U.S.C. § 355(c)(1)
About Vanda Pharmaceuticals Inc.
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.
About HETLIOZ®
For full U.S. Prescribing Information for HETLIOZ®,
including indication and Important Safety Information, visit
www.hetlioz.com.
Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.