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NOVATO, Calif., June 28, 2013 (GLOBE NEWSWIRE) -- Raptor Pharmaceutical Corp. (Nasdaq:RPTP) today announced today that the European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for PROCYSBI™ 25mg and 75mg gastro-resistant hard capsules, cysteamine (as mercaptamine bitartrate) for the treatment of proven nephropathic cystinosis. If approved, PROCYSBI will be indicated for the treatment of proven nephropathic cystinosis.
The positive opinion from CHMP must be ratified by the European Commission (EC) in order to grant marketing authorization for PROCYSBI, which would cover all 27 European Union member countries including Iceland and Norway. A decision is expected from the European Commission within a few months of the CHMP recommendation.
"The positive opinion of the CHMP brings us an important step closer to anticipated EU approval of PROCYSBI subject to the European Commission review process," said Christopher M. Starr, Ph.D., Raptor's chief executive officer. "While this recommendation is an important milestone for Raptor, it is also good news for European patients who suffer from nephropathic cystinosis."
PROCYSBI is a new therapy for the management of nephropathic cystinosis that is taken orally every twelve hours. PROCYSBI was engineered to bypass the stomach with an extended terminal half-life so that patients experience steady drug levels in their bodies for the full 12-hour dosing period. Randomized controlled clinical trials and extended treatment with PROCYSBI therapy demonstrated consistent and continuous control of white blood cell cystine.
U.S. Product Information about PROCYSBI (cysteamine bitartrate)
PROCYSBI is a cystine depleting agent that is approved in the U.S. for the management of nephropathic cystinosis in adults and children ages 6 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.