Raptor’s Procysbi gets Priority Review from Health Canada

pharmafile | March 22, 2016 | News story | Manufacturing and Production, Research and Development Canada, Health Canada, Procysbi, Raptor Pharmaceutical, genetic condition 

Raptor Pharmaceutical (Nasdaq: RPTP) said Canadian regulators have accepted a priority review for its drug to treat a rare genetic condition.

The company said it has made a New Drug Submission (NDS) with Health Canada for its Procysbi (cysteamine bitartrate) delayed-release capsules for the treatment of nephropathic cystinosis (NC).

Krishna Polu, chief medical officer of Raptor Pharmaceutical, says: “I am pleased that Procysbi has been accepted for review in Canada and that the review process will be expedited. There are currently no approved cystine depleting agents in Canada and the Priority Review status by Health Canada acknowledges the urgent unmet need Canadian patients with Cystinosis have for accessing Procysbi.”

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Priority Review provides for a shortened review process of 180 days compared to a standard 300 days. According to estimates, there are about 100 individuals affected by nephropathic cystinosis in Canada.

Procysbi, a cystine depleting agent, is approved in the US to treat NC in adults and children ages two years and older and in all patients with NC in Europe.

Anjali Shukla

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