Raptor's Procysbi new drug submission accepted by Health Canada with priority review

21 March 2016 - Raptor Pharmaceutical Corporation today announced that Health Canada has accepted for review its New Drug Submission for Procysbi (cysteamine bitartrate) delayed-release capsules for the treatment of nephropathic cystinosis (NC), with Priority Review status.

Priority Review provides for a shortened review process of 180 days compared to a standard 300 days. Raptor estimates, based on information provided by physicians, that there are approximately 100 individuals affected by nephropathic cystinosis in Canada. Procysbi, a cystine depleting agent, is approved in the U.S. for the treatment of NC in adults and children ages two years and older and in all patients with NC in Europe.

For more details, go to: http://ir.raptorpharma.com/releasedetail.cfm?ReleaseID=961581

Michael Wonder

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Michael Wonder