Navigation Links
Vanda Announces Submission To FDA Of A New Drug Application For Tasimelteon For The Treatment Of Non-24-Hour Disorder In The Totally Blind
Date:5/31/2013

WASHINGTON, May 31, 2013 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (VANDA) (NASDAQ: VNDA) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tasimelteon, a circadian regulator. Vanda is seeking FDA approval of tasimelteon for the treatment of Non-24-Hour Disorder (Non-24) in the totally blind. Tasimelteon was developed to address a significant unmet medical need, the treatment of Non-24, for which there are currently no FDA approved products.

Non-24 is a serious and rare, circadian rhythm disorder that affects the majority of totally blind individuals who lack light perception and who therefore cannot entrain (synchronize) their master body clock to the 24-hour day.  

"The NDA submission of tasimelteon for Non-24 represents a significant accomplishment for Vanda in our efforts to address unmet medical needs," said Mihael H. Polymeropoulos M.D ., Vanda's President and Chief Executive Officer.  "We are excited to have submitted an application for the first circadian regulator, representing a new class of therapeutics.  The data demonstrates that tasimelteon is able to reset the master body clock and synchronize the melatonin and cortisol circadian rhythms, resulting in significant clinical benefits to patients".   

Vanda previously announced that the FDA confirmed, at a recent pre-NDA meeting, that the efficacy, safety and supporting data package proposed to be included in the NDA would be adequate to support filing of the NDA for review by the Agency.  The tasimelteon Non-24 NDA includes data from the largest clinical program conducted to date for any investigational therapy for the treatment of Non-24.   

About Non-24-Hour Disorder
Non-24 is a serious, rare, and chronic circadian rhythm disorder characterized by the inability to entrain (synchronize) the master body clock with the 24-hour day-night cycle. Non-24 affects the majority of totally blind individuals, or between 65,000 and 95,000 people in the U.S.  Non-24 occurs almost entirely in individuals who lack the light sensitivity necessary to entrain the master body clock in the brain with the 24-hour day-night cycle.  Most people have a master body clock that naturally runs longer than 24-hours and light is the primary environmental cue that resets it to 24-hours each day.  Individuals with Non-24 have a master body clock that continually delays, resulting in prolonged periods of misalignment  between their circadian rhythms and the 24-hour day-night cycle, including the timing of melatonin and cortisol secretion and the sleep-wake cycle.  As a result of this misalignment, Non-24 is associated with significant impairments in social and occupational functioning and marked subjective distress.  For more information on Non-24, please visit www.Non-24.com.

About Tasimelteon
Tasimelteon is a circadian regulator in development for the treatment of Non-24.  Tasimelteon is a dual melatonin receptor agonist (DMRA) with selective agonist activity at the MT1 and MT2 receptors.  Tasimelteon's ability to reset the master body clock in the suprachiasmatic nucleus (SCN) results in the entrainment of the body's melatonin and cortisol rhythms with the 24-hour day-night cycle.  The patent claiming tasimelteon as a new chemical entity extends through December 2022, assuming a 5-year extension to be granted under the Hatch-Waxman Act. Tasimelteon has been granted orphan drug designation for the treatment of Non-24 from both the U.S. and the European Union. 

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.  

Company Contact:
Jim Kelly
Senior Vice President and Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com

Media Contact:
Laney Landsman
Assistant Vice President
Makovsky
(212) 508-9643
llandsman@makovsky.com  


'/>"/>
SOURCE Vanda Pharmaceuticals Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Vanda to Present Tasimelteon Non-24 Phase III Data at Two Medical Meetings
2. Vanda Pharmaceuticals Named the 2013 Life Science Firm of the Year by the Tech Council of Maryland
3. Vanda Pharmaceuticals to Announce First Quarter 2013 Financial Results on May 9, 2013
4. Vanda Pharmaceuticals to Present at the BioCentury Future Leaders in the Biotech Industry Conference
5. Vanda Reports Successful Completion Of Pre-NDA Meeting With FDA On Tasimelteon For The Treatment Of Non-24-Hour Disorder In The Totally Blind
6. Vanda Pharmaceuticals to Present at the Cowen and Company 33rd Annual Health Care Conference
7. Vanda Pharmaceuticals Reports Fourth Quarter 2012 and Full Year 2012 Results
8. Vanda Announces Phase IIb/III Clinical Study In Major Depressive Disorder Did Not Meet The Primary Endpoint
9. Vanda Announces Positive Results in the Second Phase III Study (RESET) of Tasimelteon for the Treatment of Non-24-Hour Disorder
10. Vanda Pharmaceuticals to Announce Fourth Quarter 2012 Financial Results on February 12, 2013
11. Vanda Pharmaceuticals Reports Third Quarter 2012 Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... Research and Markets has announced the addition of the "Menopause Drugs ... ... Price Analysis and Strategies - 2016, provides drug pricing data and benchmarks ... What are the key drugs marketed for ... Menopause market? What are the unit prices and annual ...
(Date:2/23/2017)... , Feb. 23, 2017 Regulus Therapeutics ... discovery and development of innovative medicines targeting microRNAs, today ... 2016 financial results on Thursday, March 2, 2017 after ... conference call and webcast on March 2, 2017 at ... full year 2016 financial results and provide a general ...
(Date:2/23/2017)... -- The fast-growing cannabis market is expected to ... . According to the 2017 Legal Marijuana Outlook, published by ... 283,422 jobs by 2020, with an implied growth rate of ... The accelerating pace of cannabis legalization is considered as the ... which will further create more business ventures and boost the ...
Breaking Medicine Technology:
(Date:2/23/2017)... , ... February 23, 2017 , ... The 89th Academy ... winner of the 2016 National Education Policy Center Bunkum Award. We invite you to ... 2016. , This year’s Bunkum winner is the Center for American Progress (CAP), for ...
(Date:2/23/2017)... (PRWEB) , ... February 23, 2017 , ... Los Angeles-based ... episodes of WE TV’s “Mama June: From Not to Hot,” which will begin airing ... “Mama” June Shannon, known to millions from the 2012 reality television series, “Here Comes ...
(Date:2/23/2017)... ... February 23, 2017 , ... On ... a diverse symposium on “Doping in Sport: How the Culture Might Change,” ... & Hampton LLP. The symposium will be held at Pepperdine University in Malibu, ...
(Date:2/23/2017)... ... February 23, 2017 , ... Current Meditation , ... begin franchising throughout the U.S. starting this spring. Current Meditation focuses on “meditation ... meditation mainstream. Current Meditation will be the first meditation concept in the U.S. ...
(Date:2/23/2017)... ... February 23, 2017 , ... CALNOC, the nation’s first and only nursing quality ... conference – Empowerment, Value and Collaboration – in Seattle, WA on October 23, 2017. ... Mason Health System in Seattle since 2000. In addition to his role at Virginia ...
Breaking Medicine News(10 mins):