The European Commission has announced that Hetlioz (tasimelteon) from US pharma company Vanda Pharmaceuticals (Nasdaq: VNDA) has been approved to treat non-24-hour sleep-wake disorder in totally blind adults.
This marketing authorization allows for the marketing of Hetlioz in all 28 European Union member states as well as European Economic Area members Iceland, Liechtenstein and Norway. It has also confirmed orphan drug designation for Hetlioz in the treatment of the disorder in totally blind adults.
Mihael Polymeropoulous, president and chief executive of Vanda, said: "The European approval of Hetlioz is an important milestone for the Non-24 patients throughout the European Union who live with this debilitating disorder.”
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