The European Commission (EC) approved Vanda Pharmaceuticals Inc’s Hetlioz (tasimelteon) for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults in the European Union (EU).

“The European approval of Hetlioz is an important milestone for the Non-24 patients throughout the European Union who live with this debilitating disorder,” says Mihael H. Polymeropoulos, MD, Vanda’s president and CEO, in a release.

The marketing authorization allows for the marketing of Hetlioz in all 28 EU member states as well as European Economic Area members Iceland, Liechtenstein, and Norway. The EC has also confirmed orphan drug designation for Hetlioz for the treatment of Non-24 in totally blind adults.