Vanda Pharma: CHMP Adopts Positive Opinion Recommending Approval Of HETLIOZ

(RTTNews) - Vanda Pharmaceuticals Inc. (VNDA) announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of HETLIOZ (tasimelteon) for the treatment of Non-24-Hour Sleep-Wake Disorder in totally blind adults in the European Union.

In 2011, HETLIOZ was 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 U.S. FDA in January 2014 and is available through specialty pharmacies in the U.S.