WASHINGTON, DC, USA I July 7, 2015 I Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that the European Commission (EC) approved HETLIOZ® (tasimelteon) for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults in the European Union (EU).
“The European approval of HETLIOZ is an important milestone for the Non-24 patients throughout the European Union who live with this debilitating disorder,” said Mihael H. Polymeropoulos, M.D., Vanda’s President and CEO.
The marketing authorization allows for the marketing of HETLIOZ® in all 28 EU member states as well as European Economic Area members Iceland, Liechtenstein and Norway. The EC has also confirmed orphan drug designation for HETLIOZ® for the treatment of Non-24 in totally blind adults.
About Non-24-Hour Sleep-Wake Disorder
Non-24 is a chronic, circadian rhythm disorder resulting from the misalignment of the endogenous master body clock to the 24-hour day, disrupting the sleep-wake cycle. The sleep disturbance causes significant distress and/or impairment in social, occupational and other important areas of functioning. Non-24 affects the majority of totally blind individuals and it has been estimated that approximately 130,000 people in the European Union have the disorder.
About HETLIOZ®
HETLIOZ® is a melatonin receptor agonist and acts as a circadian regulator that resets the master body clock in the suprachiasmatic nucleus in the brain. The benefit with HETLIOZ® is its ability to entrain the master body clock in patients with Non-24. Detailed recommendations for the use of this product are described in the summary of product characteristics (SmPC), which is published in the European public assessment report (EPAR) and available in all official European Union languages. Upon the EC public announcement of the HETLIOZ® approval, complete EU prescribing information for HETLIOZ® will be available at http://www.ema.europa.eu.
About HETLIOZ® Development
The EC approval was based on data from the HETLIOZ® clinical development program, the largest clinical research program ever conducted in Non-24. The clinical development program included two pivotal Phase 3 clinical trials, SET (Safety and Efficacy of Tasimelteon) and RESET (Randomized-withdrawal study of the Efficacy and Safety of Tasimelteon to treat Non-24).
EU Indication and Usage
HETLIOZ® is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults.
Indication and Important Safety Information About HETLIOZ® for EU Patients
HETLIOZ® may cause somnolence: After taking HETLIOZ®, patients should limit their activity to preparing for going to bed. The most common adverse reactions (incidence >3%) during clinical trials were headache, somnolence, nausea, and dizziness. The most frequently reported adverse reactions were mostly mild to moderate in severity and transient in nature.
Caution should be used when administering HETLIOZ® in combination with fluvoxamine or other strong CYP1A2 inhibitors such as ciprofloxacin and enoxacin, 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. Caution should be used when administering HETLIOZ® in combination with omeprazole or other strong CYP2C19 inhibitors because their potential to increase tasimelteon exposure has not been studied.
HETLIOZ® contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. HETLIOZ® capsules contain the azo coloring agent Orange Yellow S (E110), which may cause allergic reactions.
HETLIOZ® has not been studied in pregnant women. 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 children and its effects are unknown. HETLIOZ® is not recommended 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.
Upon the EC public announcement of the HETLIOZ® approval, complete EU prescribing information for HETLIOZ® will be available at http://www.ema.europa.eu.
About Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders. For more on Vanda, please visit www.vandapharma.com.
SOURCE: Vanda Pharmaceuticals
