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news.The European Medicines Agency (EMA) has accepted to evaluate Vanda Pharmaceuticals' Marketing Authorization Application (MAA) for oral HETLIOZ (tasimelteon) capsules for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).
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The European Commission has also granted orphan drug designation for HETLIOZ to treat Non-24 in blind people with no light perception.
In January 2014, HETLIOZ was approved by the US Food and Drug Administration (FDA) and is available through specialty pharmacies in the US.
Vanda president and CEO Mihael Polymeropoulos said the EMA submission is an important milestone towards providing a treatment option for people living with Non-24 in the European Union.
"This continues our efforts to expand the availability of HETLIOZ to markets outside the US," Polymeropoulos said.
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.
Most common adverse reactions of HETLIOZ were headache, increased alanine aminotransferase, nightmares or unusual dreams, upper respiratory or urinary tract infection.