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Canada Accepts NDA for Procysbi and Grants Priority Review - Decision on Approval Expected By June 2017

Source Link:: http://ir.raptorpharma.com/releasedetail.cfm?ReleaseID=961581

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Additional Information

Additional Relevant Details Health Canada has accepted for review its New Drug Submission (NDS) for Procysbi (cysteamine bitartrate) delayed-release capsules for the treatment of nephropathic cystinosis (NC), with Priority Review status. 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. Based off the priority review status, Health Canada has a 180 day review process, meaning a decision will be made before October 2016.

http://ir.raptorphar...

Additional Relevant Details On July 12, 2016, Raptor Pharmaceutical Corp., or Raptor, received a notice of deficiency, or NOD, from Health Canada, or HC, dated July 11, 2016 relating to the New Drug Submission, or NDS, Raptor submitted for PROCYSBI in January 2016. The NOD outlined specific deficiencies in the NDS that needed to be addressed for HC to complete its review. A complete response was submitted to HC to address the NOD on November 3, 2016. HC completed the screening process and accepted the NOD response for review on December 16, 2016. Based on a 180-day review for priority applications, we anticipate that HC will complete its review of the NDS and decide whether to grant marketing approval for PROCYSBI for the treatment of nephropathic cystinosis by June 14, 2017.

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Catalyst Date

Occurred on:

Jun 19, 2017

Occurred Source:

http://ir.horizon-pharma.com/news-releases/news-release-details/horizon-pharma-plc-announces-second-quarter-and-year-date-2017

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Related Keywords Procysbi, Nda, Priority Review, Cysteamine Bitartrate, Nephropathic Cystinosis, Health Canada