Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced today that, it received notification from the U.S. Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) aimed at treating insomnia characterized by difficulties with sleep initiation. The FDA stated that as part of its ongoing review, it has identified deficiencies that currently prevent discussions on labeling and postmarketing requirements/commitments. However, the FDA did not disclose specific deficiencies and clarified that this notification does not represent a final decision on the matter. Vanda had previously been given a Prescription Drug User Fee Act target date of March 4, 2024, for the completion of the FDA's review, as indicated in a letter dated July 17, 2023.

Vanda has conducted extensive research on the efficacy of HETLIOZ® for treating insomnia characterized by difficulties with sleep initiation. This includes a Phase III, multi-center, placebo-controlled, 4-week trial involving patients with chronic primary insomnia. Additionally, two studies focusing on transient insomnia induced by phase advance of the sleep-wake cycle were conducted, with phase advances of five hours and eight hours, respectively. These studies demonstrated a significant improvement in sleep parameters on the first night.

Vanda asserts that the timing of the FDA's communication constitutes an ongoing violation of the Federal Food, Drug, and Cosmetic Act (FDCA). According to the FDCA, the FDA must either approve a new drug application or provide an opportunity for a hearing within 180 days after the filing of an application. Vanda submitted the sNDA on May 4, 2023, making the FDA's deadline under the FDCA October 31, 2023. However, the FDA has not complied with this statute by failing to timely approve the application or provide an opportunity for a hearing within the prescribed timeframe. Vanda is also challenging the FDA's approvals of several generic versions of HETLIOZ®, which have been on the market since 2023.

Source: prnewswire.com