U.S. FDA approves circadian rhythm drug

By Reuters Staff

(Reuters) - Vanda Pharmaceuticals Inc said on Friday that U.S. health regulators have approved its experimental drug to regulate the internal body clocks of blind patients and help normalize sleep patterns.

The drug, tasimelteon (Hetlioz), is designed to treat Non-24-Hour Sleep-Wake Disorder, or Non-24, a condition that is common among the totally blind, which can cause disrupted nighttime sleep patterns and excessive daytime sleepiness.

On November 13, 2013, an advisory panel to the FDA said Hetlioz appears safe and effective.

Non-24 affects between 65,000 and 95,000 people, according to Vanda. It occurs almost exclusively in people who are deprived of light, which is needed to synchronize the body's internal clock.

Tasimelteon affects melatonin, which 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 resetting triggered by light.

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