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

"The EMA submission is an important milestone towards providing a treatment option for people living with Non-24 in the European Union," said Mihael H. Polymeropoulos, managing director, Vanda's president and chief executive officer, "This continues our efforts to expand the availability of Hetlioz to markets outside the US."

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 US.

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.