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FDA Advisors Recommend Approval of Sleep-Disorder Drug, Tasimelteon

Review set for January 2014 (November 12)

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has found that an experimental sleep-disorder treatment, tasimelteon (proposed trade name: Hetlioz, Vanda Pharmaceuticals), is sufficiently safe and effective to warrant approval.

Tasimelteon is a melatonin receptor agonist designed to treat Non–24-Hour Disorder, a rare circadian-rhythm disorder that is most commonly found in the totally blind and can cause disrupted nighttime sleep patterns and excessive daytime sleepiness.

The FDA is scheduled to make a decision on whether to approve the drug by January 31, 2014.

In its clinical review, the agency’s advisory panel offered the following overall risk–benefit assessment: “The efficacy for tasimelteon in the treatment of Non–24-Hour Disorder has been demonstrated on clinical outcomes in two clinical studies. There are no major safety issues associated with the use of tasimelteon in the submitted safety database, which includes subjects with Non–24-Hour Disorder. The clinical benefit outweighs the risks in subjects with Non–24-Hour Disorder.”

The FDA is not obligated to follow its advisors’ recommendations, but it usually does so.

Source: FDA; November 12, 2013.

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