Savient Pharmaceuticals's Krystexxa (pegloticase) has received positive opinion recommending approval of a marketing authorization from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) following the completion of its scientific assessment.
The EMA's opinion if ratified by European Commission will enable Krystexxa to treat tophaceous gout patients, who have failed to normalise serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated.
Savient president and chief executive officer Louis Ferrari said, ''The CHMP's positive opinion marks an important step forward in addressing the significant unmet medical need that currently exists in Europe; and we look forward to receiving the final decision from the European Commission."
The positive CHMP opinion is the outcome of assessment of the Marketing Authorization Application (MAA), which included safety and efficacy data from Savient's two pivotal phase III studies, and a long-term open label extension study of Krystexxa.
Krystexxa is a PEGylated uric acid specific enzyme to be infused intravenously and has pegloticase, a covalent conjugate of uricase produced by a genetically modified strain of Escherichia coli and monomethoxypoly (ethylene glycol).
