The FDA’s Arthritis Drugs Advisory Committee has recommended that Krystexxa (pegloticase) be approved for treating refractory chronic gout. The FDA has granted orphan drug status to pegloticase, a biologic PEGylated uricase enzyme.
Paul Hamelin, R.Ph., President of Savient Pharmaceuticals, New Brunswick, N.J., the drug’s developer, said in a press release that the advisory committee’s recommendation supports the company’s belief that the drug has a favorable risk-to-benefit profile in patients with refractory chronic gout.
The FDA granted priority review status to Savient’s Biologics License Application (BLA) for pegloticase. The target date for an FDA decision on this BLA is August 1.