CHMP recommends Hetlioz (tasimelteon) for Non-24-Hour Sleep-Wake Disorder - Vanda Pharma

Vanda Pharmaceuticals Inc.has announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Hetlioz (tasimelteon) for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults in the European Union (EU). The CHMP positive opinion will be reviewed by the European Commission (EC). The EC usually issues a final decision within two months of a CHMP opinion.

In 2011, Hetlioz was granted orphan drug designation for the treatment of Non-24 in blind people with no light perception from the EC. Hetlioz was approved by the FDA in January 2014 and is available through specialty pharmacies in the U.S.

Comment: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 US. 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.