Vanda Pharmaceuticals Announces FDA Update for supplemental NDA for HETLIOZ® in the Treatment of Insomnia

Rhea-AI Summary

Vanda Pharmaceuticals Inc. received a notification from the FDA regarding the ongoing review of its supplemental New Drug Application for HETLIOZ. The FDA identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. Vanda believes that the timing of the FDA's communication is part of an ongoing violation of the FDCA. The company is also challenging the FDA's approvals of several generic versions of HETLIOZ, which have been marketed since 2023.

Positive

• Vanda Pharmaceuticals Inc. 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 significant effects the first night in improving sleep parameters.

Negative

• The FDA identified deficiencies in Vanda's supplemental New Drug Application, which could affect the approval process and marketing of HETLIOZ. Vanda is challenging the FDA's approvals of generic versions of HETLIOZ, potentially leading to legal disputes and regulatory challenges.

Insights

Pharmaceutical Regulatory Expert

Understanding the regulatory process is crucial for assessing the potential impact of the FDA's notification on Vanda Pharmaceuticals. The FDA's identification of deficiencies in the sNDA for HETLIOZ® indicates that there are outstanding issues that need to be resolved before the drug can be approved for the new indication of insomnia. This is a significant hurdle because it not only delays potential market entry but also creates uncertainty for investors and the company. The delay in approval could have financial implications, such as increased costs associated with additional data collection or extended review times.

Moreover, the company's claim of an ongoing violation of the FDCA by the FDA is a serious allegation that suggests potential legal disputes. Such disputes can further delay the approval process and may require legal resources that could otherwise be allocated to product development or marketing. The outcome of these challenges could set precedents that impact future regulatory submissions, not only for Vanda but for the entire pharmaceutical industry.

Financial Analyst

The market typically reacts to uncertainty and the FDA's notification could be perceived negatively by investors, potentially affecting Vanda's stock price. The delay in approval may lead to revisions in revenue forecasts and could impact the company's cash flow projections. Moreover, the launch of generic versions of HETLIOZ® could erode the brand's market share and revenue, particularly if the sNDA approval is further delayed. It is essential to monitor Vanda's financial health, including its cash reserves and burn rate, to understand how these regulatory challenges might affect its financial sustainability.

Market Research Analyst

The insomnia treatment market is competitive, with several established products and new treatments entering the market. Vanda's ability to secure approval for HETLIOZ® in this new indication could significantly expand its market reach, provided the deficiencies identified by the FDA can be addressed. An understanding of the market size, growth projections and competitive landscape is critical to evaluating the potential impact of HETLIOZ®'s approval on Vanda's market position. Additionally, the timing of market entry is key, as delays could result in lost market opportunities, especially with generic competition already in place.

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

1. 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.

FAQ

What notification did Vanda Pharmaceuticals Inc. receive from the FDA?

Vanda Pharmaceuticals Inc. received a notification from the FDA regarding the ongoing review of its supplemental New Drug Application for HETLIOZ.

What did the FDA identify in the notification?

The FDA identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time.

What is Vanda challenging regarding the FDA's approvals?

Vanda is challenging the FDA's approvals of several generic versions of HETLIOZ, which have been marketed since 2023.

What did Vanda study in relation to HETLIOZ?

Vanda has extensively studied the efficacy of HETLIOZ in the treatment of insomnia characterized by difficulties with sleep initiation, including a Phase III, multi-center, placebo-controlled, 4-week trial and transient insomnia studies induced by phase advance of the sleep-wake cycle.