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Vanda Pharmaceuticals Inc. (Vanda), a specialty pharmaceutical company, announced that Hetlioz (tasimelteon) is now available for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in Germany.
"The launch of Hetlioz in Germany reflects our continued focus to bring a treatment option to Non-24 patients across the globe," said Gian Piero Reverberi, Vanda's senior vice president and chief commercial officer
"We are very pleased with our first Hetlioz launch outside of the United States and look forward to making Hetlioz available in additional countries in the coming years." In July 2015,
The European Commission (EC) approved Hetlioz for the treatment of Non-24 in totally blind adults in all 28 European Union (EU) member states as well as European Economic Area members Iceland, Liechtenstein and Norway.
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 or impairment in social, occupational and other important areas of functioning.
Hetlioz is a melatonin receptor agonist. Hetlioz has been approved by the EC and received orphan drug designation for the treatment of Non-24 in totally blind adults in the EU.
Hetlioz has been approved by the US Food and Drug Administration and received orphan drug designation for the treatment of Non-24.
