FDA accepts filing of Hetlioz as a treatment for Jet Lag disorder.- Vanda Pharma
Vanda Pharmaceuticals Inc. announced that the FDA has accepted the filing of Vanda's Supplemental New Drug Application for Hetlioz (tasimelteon) for the treatment of jet lag disorder. The FDA determined the action target date under Prescription Drug User Fee Act (PDUFA-VI), to be 16 August 2019.
Hetlioz is currently approved for the treatment of Non-24 Hour Sleep Wake Disorder. .
Comment: The most common adverse reactions (incidence more than 5% and at least twice as high on Hetlioz (tasimelteon) than on placebo) were headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infection. The risk of adverse reactions may be greater in elderly (older than 65 years) patients than younger patients because exposure to Hetlioz is increased by approximately 2-fold compared with younger patients.
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