The 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," said Mihael H. Polymeropoulos, M.D., Vanda's president and chief executive officer.

The CHMP positive opinion will be reviewed by the European Commission (EC). If approved, the EC grants a centralized marketing authorization with unified labelling 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.

On 23 April 2015, CHMP adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Hetlioz, intended for the treatment of non-24-hour sleep-wake disorder in totally blind adults.

Hetlioz will be available as 20 mg hard capsules. The active substance of Hetlioz is tasimelteon, a psycholeptic (ATC code: N05CH03). Tasimelteon is a melatonin receptor agonist and acts as a circadian regulator that resets the master body clock in the suprachiasmatic nucleus.

The benefit with Hetlioz is its ability to entrain the master body clock in patients with non-24-hour sleep-wake disorder. The most common side effects are headache, somnolence, and nightmares or unusual dreams.

Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Non-24 was first described more than 60 years ago, and 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 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.

Vanda Pharmaceuticals Inc is a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders.