90 FR 44 pg. 11542 - Notice of the Denial of a Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon)
Type: NOTICEVolume: 90Number: 44Page: 11542
Page: 11542Docket number: [Docket No. FDA-2022-N-2390]
FR document: [FR Doc. 2025-03697 Filed 3-6-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2390]
Notice of the Denial of a Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon)
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is announcing the availability of the decision to deny a request for a hearing regarding the proposal of the Center for Drug Evaluation and Research (CDER) to refuse to approve the supplemental new drug application (sNDA) 205677-012, submitted by Vanda Pharmaceuticals, Inc. (Vanda), for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), for the treatment of insomnia characterized by difficulties with sleep initiation. The decision, which also refuses approval of sNDA 205677-012, is available in the docket identified by the number in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Rachael Vieder Linowes, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 240-402-5931.
SUPPLEMENTARY INFORMATION:
I. Background
On January 31, 2014, FDA approved new drug application (NDA) 205677 for HETLIOZ (tasimelteon) for treatment of non-24-hour sleep-wake disorder, a circadian-rhythm disorder that disproportionately afflicts individuals who are totally blind. On December 1, 2020, FDA approved NDA 214517 for HETLIOZ (tasimelteon) suspension for the treatment of nighttime sleep disturbances in pediatric patients with Smith-Magenis Syndrome, a rare genetic neurodevelopment disorder. On May 4, 2023, Vanda submitted the sNDA that is the subject at issue here: sNDA 205677-012 for HETLIOZ (tasimelteon) capsules, 20 mg, as an efficacy supplement proposing to add a new indication for the treatment of insomnia characterized by difficulties with sleep initiation.
On March 4, 2024, CDER issued a complete response letter to Vanda stating that sNDA 205677-012 could not be approved in its present form because the application does not provide substantial evidence of effectiveness for tasimelteon for the proposed indication-treatment of insomnia characterized by difficulties with sleep initiation, nor does the application demonstrate that the drug is safe for this use. Following the complete response letter, in a letter dated April 11, 2024, Vanda indicated that it wished to receive approval of its application or a notice of opportunity for a hearing (NOOH). On June 6, 2024, CDER notified Vanda by electronic mail, providing it with a NOOH on a proposal to refuse to approve sNDA 205677-012. The NOOH was subsequently published in the Federal Register of June 7, 2024 (89 FR 48647) and described the grounds on which the application failed to meet the criteria for approval under section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)).
On July 3, 2024, Vanda filed a notice of participation and requested a hearing, and, on August 6, 2024, Vanda submitted information, data, and analyses in support of that request. On October 31, 2024, CDER submitted a proposed order denying Vanda's request for a hearing and refusing to approve the sNDA. On December 31, 2024, Vanda submitted a response to CDER's proposed order.
After considering the parties' submissions, on February 28, 2025, FDA issued a decision denying Vanda's request for a hearing on CDER's proposal to refuse approval and refusing to approve sNDA 205677-012.
II. Electronic Access
Persons with access to the internet may obtain the final decision at https://www.regulations.gov/docket/FDA-2022-N-2390 . The final decision and other documents pertaining to the refusal to approve HETLIOZ (sNDA 205677-012) are available at https://www.regulations.gov under the docket number found in brackets in the heading of this document.
Dated: March 4, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-03697 Filed 3-6-25; 8:45 am]
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