FDA panel to weigh Savient’s Puricase for gout
Executive Summary
FDA's Arthritis Drugs Advisory Committee will evaluate the BLA for Savient Pharmaceutical's Puricase (pegloticase) for the orphan indication of treatment-failure gout. Under priority review, the product's action date is April 20 1("The Pink Sheet" DAILY, Dec. 29, 2008). Late last year, the panel unanimously recommended Takeda's gout therapy febuxostat (2"The Pink Sheet" DAILY, Nov. 24, 2008)