Vanda’s HETLIOZ MAA for Non-24-Hour Sleep-Wake Disorder accepted for evaluation by the EMA

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.



The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News-Medical.Net.
Post a new comment
You might also like... ×
Menopausal changes have detrimental effects on sleep patterns