Vanda’s HETLIOZ MAA for Non-24-Hour Sleep-Wake Disorder accepted for evaluation by the EMA
Published on June 3, 2014 at 8:47 AM
Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) announced today 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 H. Polymeropoulos, M.D., 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 U.S.
Vanda Pharmaceuticals Inc.