European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Vanda Pharmaceuticals’ Hetlioz (tasimelteon) for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults in the European Union (EU).
“The positive opinion by CHMP on Hetlioz is another milestone on the road to approval in the EU and the building of a global brand to benefit patients with Non-24 throughout the world,” says Mihael H. Polymeropoulos, MD, Vanda’s President and CEO, in a release.
The CHMP positive opinion will be reviewed by the European Commission (EC). If approved, the EC grants a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the EU, as well as European Economic Area members Iceland, Liechtenstein, and Norway. The EC usually issues a final decision within two months of a CHMP opinion.
In 2011, Hetlioz was granted orphan drug designation for the treatment of Non-24 in blind people with no light perception from the EC. Hetlioz was approved by the US Food and Drug Administration in January 2014 and is available through specialty pharmacies in the US.