FDA Accepts HETLIOZ® (tasimelteon) Supplemental New Drug Application for Review in the Treatment of Jet Lag Disorder

News provided by

Dec 20, 2018, 07:00 ET

WASHINGTON, Dec. 20, 2018 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of Vanda's Supplemental New Drug Application for HETLIOZ^® (tasimelteon) for the treatment of jet lag disorder.

The FDA determined the action target date under Prescription Drug User Fee Act (PDUFA-VI), to be August 16, 2019.

HETLIOZ^® is currently approved for the treatment of Non-24 Hour Sleep Wake Disorder. For a review of the current prescribing information of HETLIOZ^® please visit www.hetlioz.com.

About HETLIOZ^® (tasimelteon)

HETLIOZ^® (tasimelteon) is a melatonin receptor agonist. HETLIOZ^® has been granted market authorization by the U.S. Food and Drug Administration and the European Medicines Agency. For full U.S. prescribing information, please visit www.hetlioz.com.

Important Safety Information

The most common adverse reactions (incidence >5% and at least twice as high on HETLIOZ^® (tasimelteon) than on placebo) were headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infection. The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to HETLIOZ^® is increased by approximately 2-fold compared with younger patients.

Indication

HETLIOZ^® is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).

Important Safety Information

HETLIOZ^® may cause somnolence: After taking HETLIOZ^®, patients should limit their activity to preparing for going to bed, because HETLIOZ^® can potentially impair the performance of activities requiring complete mental alertness.

The most common adverse reactions (incidence >5% and at least twice as high on HETLIOZ^® than on placebo) were headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infection. The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to HETLIOZ^® is increased by approximately 2-fold compared with younger patients.

Use of HETLIOZ^® should be avoided in combination with fluvoxamine or other strong CYP1A2 inhibitors, because of a potentially large increase in exposure of HETLIOZ^®, and a greater risk of adverse reactions. HETLIOZ^® should be avoided in combination with rifampin or other CYP3A4 inducers, because of a potentially large decrease in exposure of HETLIOZ^®, with reduced efficacy.

There are no adequate and well-controlled studies of HETLIOZ^® in pregnant women. Based on animal data, HETLIOZ^®may cause fetal harm. HETLIOZ^® should be used during pregnancy only if the potential benefit justifies the potential risks. Caution should be exercised when HETLIOZ^® is administered to a nursing woman.

HETLIOZ^® has not been studied in patients with severe hepatic impairment and is not recommended in these patients.

Safety and effectiveness of HETLIOZ^® in pediatric patients have not been established.

About Vanda

Vanda is a 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.

HETLIOZ^®is Vanda's registered trademark. Any other trademarks, registered marks and trade names and service marks appearing in this release are the property of their respective holders.

Corporate Contact:
Jim Kelly
Executive Vice President and Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
[email protected]

SOURCE Vanda Pharmaceuticals Inc.