FDA Approves Vanda’s Hetlioz For Circadian Rhythm Disorder

Vanda Pharmaceuticals Inc. Jan. 31 said that the Food and Drug Administration has approved Hetlioz (tasimelteon) 20 mg capsules for treating non-24-hour sleep-wake disorder.

Hetlioz is the first medication the FDA has approved for non-24, a chronic, circadian rhythm disorder resulting when the endogenous master body clock doesn’t align with the 24-hour day, disrupting the sleep-wake cycle, the Washington-based company said. Non-24 affects the majority of totally blind individuals. The FDA said in a separate statement that although most people who are totally blind still can perceive light well enough to prevent non-24, there may be as many as 100,000 ...