Vanda’s Hetlioz approved in EU to treat non-24-hour sleep-wake disorder in totally blind people

Non-24 is a chronic, circadian rhythm disorder which results from the misalignment of the endogenous master body clock to the 24-hour day, disrupting the sleep-wake cycle.

Hetlioz is a melatonin receptor agonist that and acts as a circadian regulator that resets the master body clock in the suprachiasmatic nucleus in the brain.

The EC approval was based on data from the Hetlioz clinical development program, which included two pivotal Phase III clinical trials, Safety and Efficacy of Tasimelteon (SET) and Randomized-withdrawal study of the Efficacy and Safety of Tasimelteon to treat Non-24 (RESET).

Vanda president and CEO Mihael Polymeropoulos 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."

The approval allows for the marketing of Hetlioz in all 28 EU member states as well as European Economic Area members Iceland, Liechtenstein and Norway.

Additionally, the EC has also confirmed orphan drug status for Hetlioz to treat Non-24 in totally blind adults.

The company noted that sleep disturbance causes significant distress and/or impairment in social, occupational and other important areas of functioning.

Non-24, which affects the majority of totally blind individuals, has been estimated that about 130,000 people in the EU have the disorder.