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June 3, 2014
08:15 EDTHPTXHyperion Therapeutics announces RAVICTI NDS accepted by Health Canada
Hyperion Therapeutics announced that the validation period is complete for its New Drug Submission to Health Canada for RAVICTI Oral Liquid for the treatment of urea cycle disorders, and that the RAVICTI NDS was granted Priority Review. Standard review in Canada takes 18 months or more and Priority Review, which is granted to promising medicines that address life-threatening or severely debilitating conditions, shortens the review time to approximately six months. The NDS is based on results from 10 controlled and uncontrolled clinical trials studying the safety and efficacy of RAVICTI in 359 patients across three populations, including 114 UCD patients. Data from multiple Canadian patients enrolled at the University of Toronto were included in the submission. The safety and efficacy of RAVICTI is under review by Health Canada and market authorization has not yet been granted.
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