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news.The European Commission has given orphan drug status to Vanda Pharmaceuticals for Tasimelteon, an oral dual melatonin receptor agonist in Phase III clinical trials for Non-24-Hour Sleep/Wake Disorder (N24HSWD) in blind individuals with no light perception.
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This follows the positive opinion on the designation that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency adopted previously in the November 2010 COMP Committee Meeting.
Vanda Pharma president and CEO Mihael Polymeropoulos said they are very pleased to receive orphan designation from the European Commission.
"This status represents an acknowledgement of the significant unmet medical need to develop and commercialize a treatment that may alleviate sleep/wake problems in people who are totally blind with no light perception," Polymeropoulos said.