Savient's Krystexxa gets final EU approval for chronic tophaceous gout

US drugmaker Savient Pharmaceuticals (Nasdaq: SVNT) says that the European Commission has granted a marketing authorization 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.

"There is currently no other treatment option in the [European Union] for patients with severe chronic tophaceous gout who do not respond to oral xanthine oxidase inhibitors," said Thomas Bardin, Professor and head of the Rheumatology department at the Lariboisiere Hospital in Paris, France, adding: " Krystexxa addresses a significant unmet medical need and represents an important development for health care professionals and European patients suffering from this debilitating disease."

Product launch expected mid-2013