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Health Canada accepts for review Raptor's Procysbi NDA to treat nephropathic cystinosis

Novato, California
Wednesday, March 23, 2016, 17:30 Hrs  [IST]

Raptor Pharmaceutical Corp, a global biopharmaceutical company, announced that 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.

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 US for the treatment of NC in adults and children ages two years and older and in all patients with NC in Europe.

"I am pleased that Procysbi has been accepted for review in Canada and that the review process will be expedited," said Krishna Polu, M.D., chief medical officer of Raptor Pharmaceutical Corp. "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."

Procysbi is a cystine depleting agent that is approved in the US for the treatment of nephropathic cystinosis in adults and children ages two years and older. It is contraindicated in patients with a hypersensitivity to penicillamine. The most commonly reported side effects are vomiting, abdominal pain/discomfort, headaches, nausea, diarrhea, anorexia/decreased appetite, breath odor, fatigue, dizziness, skin odor and rash.

 

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