FDA advisory panel votes in favor of AstraZeneca drug for gout patients

Anglo-Swedish pharma major AstraZeneca (LSE: AZN) said on Friday that the US Food and Drug Administration’s 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 program trials, representing the largest clinical trial data set of gout patients treated with combination urate lowering therapy. AstraZeneca's shares were up just under 1% at $31.36 in late afternoon trading in the USA.

The FDA is not bound by the Advisory Committee’s recommendation but takes its advice into consideration when reviewing the application for a potential medicine. The Prescription Drug User Fee Act (PDUFA) target goal date for lesinurad is 29 December 2015.