Oct. 19, 2012
/PRNewswire/ -- Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) and its wholly owned subsidiary, Savient Pharma Ireland Limited, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has completed its scientific assessment and has issued a positive opinion recommending approval of a marketing authorization in the European Union for KRYSTEXXA
(pegloticase) for the treatment of severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated. This opinion will be transmitted to the European Commission, which has the authority for granting marketing authorisations in the EU. If such marketing authorization is granted, KRYSTEXXA will address a significant unmet medical need for certain patients with refractory chronic gout (RCG) in the European Union.
"This is a major milestone in our ongoing commitment to advance care for patients who suffer from this burdensome and debilitating disease. 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," said
, President and Chief Executive Officer of Savient.
The positive CHMP opinion was based upon a detailed evaluation 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, as well as non-clinical and chemistry, manufacturing and control information.
ABOUT REFRACTORY CHRONIC GOUT
Symptoms of gout are caused by the body's response to the presence of high uric acid levels which can lead to the formation of uric acid crystals in the joints and surrounding tissue, which form when uric acid levels in the blood are elevated (a condition called hyperuricemia). The longer hyperuricemia persists, the higher the risk of developing gout. Symptoms of gout may include painful flares, pain or swelling in the joints (known as "gouty arthritis") or deposits of uric acid crystals under the skin, called "tophi." Although most cases of gout can be controlled with conventional urate-lowering therapy, when uric acid levels remain high and symptoms persist despite treatment efforts, chronic gout may be defined as refractory.
In cases of severe debilitating chronic tophaceous gout, these symptoms have a major influence on patient health-related quality of life due to the frequency and severity of episodes and the recurrent pain, and can also lead to disfigurement associated with this condition.