Raptor Pharmaceutical has announced FDA acceptance of new drug application (NDA) for Cysteamine Bitartrate delayed-release capsules (RP103) for the potential treatment of nephropathic cystinosis.
RP103 gained standard review designation by FDA.
The data from Raptor's Phase 3 cystinosis trial of RP103, which met sole primary endpoint, was included in the NDA submission.
Raptor chief executive officer Christopher Starr said, "We are focused and working hard to build our internal and external infrastructure in order to support a robust commercial launch so that Raptor can quickly provide this important therapeutic to the cystinosis community in the US and the European Union."
The European Medicines Agency already validated the marketing authorization application for RP103, for the potential treatment of nephropathic cystinosis, and it is now under review.
The company expects a decision in the first half of 2013.
