FDA ADVISORY COMMITTEE RECOMMENDS THE APPROVAL OF LESINURAD FOR GOUT PATIENTS
AstraZeneca has announced that the US Food and Drug Administration's (FDA) Arthritis Advisory Committee (AAC) voted 10 to 4 to recommend the approval of lesinurad 200mg tablets for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI). The AAC reviewed safety and efficacy data from the pivotal Phase III combination therapy programme trials, representing the largest clinical trial data set of gout patients treated with combination urate lowering therapy. The FDA is not bound by the Advisory Committee's recommendation but takes its