Vanda Pharmaceuticals Inc‘s Marketing Authorization 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,” says Mihael H. Polymeropoulos, MD, Vanda’s president and CEO, in a release. “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 United States.