Vanda Pharmaceuticals Inc. announced that its 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,” said Mihael Polymeropoulos, Vanda’s president and CEO. “This continues our efforts to expand the availability of Hetlioz to markets outside the U.S.”
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.
Date: June 3, 2014
Source: Vanda Pharmaceuticals