Raptor Pharmaceutical Corp. (RPTP), on Tuesday said that the U.S. Food and Drug Administration or FDA has approved PROCYSBI, the company's drug for the treatment of nephropathic cystinosis in adults and children.
The company in a statement added that the Phase 3 study of PROCYSBI revealed sucessful cystine depletion, studies show that sustained cystine depletion in patients may significantly delay disease progression, including kidney dysfunction, dialysis, kidney transplant, organ failure and premature death.
The FDA approval of PROCYSBI was based on a New Drug Application, comprising data from six clinical trials, including a multi-center randomized, active-controlled Phase 3 trial of 43 patients with nephropathic cystinosis, said Raptor.
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