The European Commission (EC) has granted marketing authorisation for 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," said Mihael H. Polymeropoulos, M.D., Vanda's president and chief executive officer.
The marketing authorisation 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.
Non-24 is a chronic, circadian rhythm disorder resulting from the misalignment of the endogenous master body clock to the 24-hour day, disrupting the sleep-wake cycle. The sleep disturbance causes significant distress and/or impairment in social, occupational and other important areas of functioning. Non-24 affects the majority of totally blind individuals and it has been estimated that approximately 130,000 people in the European Union have the disorder.
Hetlioz is a melatonin receptor agonist and acts as a circadian regulator that resets the master body clock in the suprachiasmatic nucleus in the brain. The benefit with Hetlioz is its ability to entrain the master body clock in patients with Non-24.
The EC approval was based on data from the Hetlioz clinical development programme, the largest clinical research programme ever conducted in Non-24. The clinical development programme included two pivotal phase 3 clinical trials, SET (Safety and Efficacy of Tasimelteon) and RESET (Randomized-withdrawal study of the Efficacy and Safety of Tasimelteon to treat Non-24).
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialisation of products for the treatment of central nervous system disorders.