Vanda Pharma Says EMA Accepts Hetlioz MAA For Non-24-Hour Sleep-Wake Disorder

(RTTNews) - Vanda Pharmaceuticals Inc. (VNDA) announced Tuesday that its Marketing Authorization Application or MAA for oral Hetlioz or tasimelteon capsules has been accepted for evaluation by the European Medicines Agency or EMA for the treatment of Non-24-Hour Sleep-Wake Disorder.

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

Non-24 was first described more than 60 years ago, and is a chronic, circadian rhythm disorder resulting from the misalignment of the endogenous master body clock to the 24-hour day, disrupting the sleep-wake cycle. The sleep disturbance causes significant distress or impairment in social, occupational and other important areas of functioning. Non-24 affects the majority of totally blind individuals and it is estimated that approximately 130,000 people in the European Union have the disorder.