Hetlioz is filed at EMA for Non 24 Hour Sleep-Wake Disorder - Vanda Pharma

Vanda Pharmaceuticals announced that its MAA for oral Hetlioz capsules has been accepted for evaluation by the EMA for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). Hetlioz has been granted orphan drug designation for the treatment of Non-24 in blind people with no light perception from the European Commission. It was approved by the FDA in January 2014.

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.