WASHINGTON, DC, USA I January 31, 2014 I Vanda Pharmaceuticals Inc. (VANDA) (NASDAQ: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved HETLIOZ™ (tasimelteon) 20mg capsules for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). HETLIOZ™ is the first FDA approved medication for Non-24.
Non-24 was first described more than 60 years ago, and 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. Non-24 affects the majority of totally blind individuals and it is estimated that approximately 80,000 Americans have the disorder.
“The FDA approval of HETLIOZ™ would not have been accomplished without the heroic efforts of blind patients and their advocates,” said Mihael H. Polymeropoulos, M.D., Vanda’s President and Chief Executive Officer. “We are committed to providing much needed support to patients with Non-24 and facilitating access to this new therapeutic option.”
The approval of HETLIOZ™ was based on two key efficacy studies and the safety has been evaluated in over 1,300 individuals.
The most common adverse reactions in the clinical trials were headache, increased alanine aminotransferase, nightmares or unusual dreams, upper respiratory or urinary tract infection. After taking HETLIOZ™, patients should limit their activity to preparing for going to bed because HETLIOZ™ can impair the performance of activities requiring complete mental alertness.
“Totally blind people have struggled with the problems brought on by Non-24-Hour Sleep-Wake Disorder, sometimes for their entire life, without understanding what causes it and without being able to do anything about it,” said Steven W. Lockley, Ph.D., Division of Sleep Medicine, Brigham and Women’s Hospital, a teaching affiliate of Harvard Medical School. “Today’s FDA approval of HETLIOZ™ means that, for the first time, these patients have access to an approved, safe and effective treatment for their difficult debilitating disorder.”
Vanda anticipates making HETLIOZ™ commercially available in the second quarter of 2014.
Conference Call for Investors
Vanda Pharmaceuticals will host a conference call for investors, Monday, February 3, 2014 at 10:00 AM ET, to discuss the FDA’s approval of HETLIOZ™. Investors can call 1-888-895-5271 (domestic) and 1-847-619-6547 (international) and use passcode 36581091. A replay of the call will be available beginning Monday, February 3, 2014 at 12:30 PM ET and will be accessible until Monday, February 10, 2014, at 11:59 PM ET. The replay call-in number is 1-888-843-7419 for domestic callers and 1-630-652-3042 for international callers. The access number is 36581091.
The conference call will be broadcast simultaneously on Vanda’s website, www.vandapharma.com. Investors should click on the Investor Relations tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda’s website for a period of 30 days.
About HETLIOZ™
Full HETLIOZ™ Prescribing Information can be found at: www.hetlioz.com
For more information about HETLIOZ™ call 1-844-HETLIOZ (1-844-438-5469).
Indication and Important Safety Information About HETLIOZ™
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 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, 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.
Full HETLIOZ™ Prescribing Information can be found at: www.hetlioz.com
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
