FDA Advisory Committee Recommends the Approval of Lesinurad for Gout Patients


AstraZeneca today announced that the US Food and Drug Administration's (FDA) Arthritis Advisory Committee (AAC) voted 10-4 to recommend the approval of lesinurad 200 mg 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.

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 December 29, 2015.

If approved, lesinurad will be the first selective uric acid reabsorption inhibitor, or SURI, in the US. It inhibits the urate transporter, URAT1, which is responsible for the majority of the renal reabsorption of uric acid.

Sean Bohen, Executive Vice President of Global Medicines Development and Chief Medical Officer, AstraZeneca, said: "The Committee's positive recommendation for lesinurad is an encouraging step for patients suffering from the debilitating effects of gout, a disease in which there has been limited treatment innovation over the last 50 years. We look forward to the outcome of the FDA's review and the opportunity to provide a new treatment option that when combined with an XOI addresses both the under-excretion and over-production of uric acid, the underlying causes of gout."

Gout is a serious and debilitating form of inflammatory arthritis caused by hyperuricemia (elevated serum uric acid (sUA)). Gout affects millions of Americans, many of whom do not reach recommended sUA treatment goals on the current standard of care (XOIs), which decrease production of uric acid. For those inadequately controlled patients, the addition of a urate lowering therapy to increase excretion of uric acid, may help them achieve treatment goals.

Lesinurad is also under regulatory review in the European Union and other territories.