Drugs

Vanda sNDA Hetlioz Review Hits Snag: FDA

FDA has told Vanda Pharmaceuticals that its ongoing review of a Hetlioz (tasimelteon) supplemental NDA has “identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time,” according to the company. The submission seeks the drug’s use for treating insomnia characterized by difficulties with sleep initiation. Currently, Hetlioz is approved for treating non-24-hour sleep-wake disorder and nighttime sleep disturbances in Smith-Magenis Syndrome patients.

“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,” Vanda says. The submission has been given a 3/4 user fee review action target date.

Vanda argues that its user fee date is a 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,” it says. “Because Vanda submitted the sNDA on 5/4/2023, the FDA's deadline under the FDCA was 10/31/2023. 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 has had a rocky relationship with FDA over several reviews and approvals of generic competitors to its products being approved ahead of them. Recently, the DC federal court ordered FDA to either resolve a Vanda sNDA for Hetlioz to treat jet lag disorder or start a hearing on the sNDA on or before 3/5. The court’s ruling came as it granted Vanda summary judgment in its 9/2022 suit claiming that the agency did not meet its legal obligations to either approve the sNDA or provide an opportunity for a hearing (see earlier story).

In a statement, Vanda says it submitted that sNDA in 10/2018. The statement quotes the court’s decision that “the statute requires that a hearing shall commence within 300 days after an application is filed. Vanda’s application has been pending for almost 2,000 days and it has been over 500 days since Vanda made its most recent request for a hearing.” The company says the decision “highlights the serious flaws in FDA regulations governing drug approval processes and it reinforces FDA’s clear statutory obligations to render timely final decisions on drug applications."

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