FDA
15th November 2013

FDA Supports tasimelteon for Sleep Regulation Disorder

Yesterday, the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee overwhelmingly voted in favor of recommending approval of Vanda’s New Drug Application (NDA) for tasimelteon, proposed tradename HETLIOZ™.

FDA Supports tasimelteon for Sleep Regulation Disorder

Yesterday, the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee overwhelmingly voted in favor of recommending approval of Vanda’s New Drug Application (NDA) for tasimelteon, proposed tradename HETLIOZ™. Tasimelteon is designed for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in blind individuals. 

Non-24 is a chronic circadian rhythm sleep disorder. It can be described as an abnormal synchronization between the 24-hour light–dark cycle and the endogenous circadian rhythms of sleep and wake. This condition often affects those who are deprived of light, which is needed to synchronize the body’s internal clock. Thus, the disorder is almost exclusively found in the totally blind and can cause disrupted nighttime sleep patterns (e.g. insomnia) and excessive daytime sleepiness. 

Tasimelteon affects melatonin, a hormone produced by the body’s pineal gland that plays a key role in regulating the body’s master circadian clock. When taken before bed, it resets the circadian clock by replacing the normal setting triggered by light.

The committee determined tasimelteon to be both safe and effective based on the results of two clinical trials. Vanda said the drug offered improvements to patients across a variety of sleep and wake parameters including measures of total sleep time and daytime nap duration.

“We are extremely pleased that the FDA’s advisory committee has recommended that the FDA approve HETLIOZ™ for the treatment of Non-24 in the totally blind,” said Mihael H. Polymeropoulos M.D., Vanda’s President and Chief Executive Officer. “We are now one step closer toward our goal of providing a treatment option that addresses the physiologic cause of this serious, debilitating orphan condition that impacts a majority of totally blind individuals.”

Vanda’s NDA is currently under Priority Review by the FDA for the treatment of Non-24 in the totally blind, with an action target date under the Prescription Drug User Fee Act (PDUFA-V) of January 31, 2014.  

Furthermore, tasimelteon has been given Orphan Drug status by the FDA. Orphan drugs are designed to treat diseases that affect fewer than 200,000 people. If approved, the drug would receive seven years of U.S. market exclusivity, and would be the first approved treatment for this disorder.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

Do you want a more detailed analysis of this drug’s FDA AdComm meeting? Great news – ISS can help you! Click on the link below in order to receive a detailed post-meeting outcome report! 

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