FDA Committee Recommends Approval for Lesinurad for Gout

The 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 recommendation comes on the heels of pivotal phase III safety and efficacy data of the combination therapy.

The recommendation should not be confused with FDA approval of the drug; the FDA is not bound by the Advisory Committee’s recommendation, but it takes its advice into consideration when reviewing the application for a potential medicine. The FDA is expected to make a decision on approval for lesinurad before the end of the year.

The drug is not meant to be a first-line therapy for gout treatment. Rather, it is designed to be used in combination with febuxostat as add-on therapy for gout patients who are not reaching target uric acid levels after first-line treatment.

Lesinurad works by decreasing the production of uric acid and increasing its excretion. Estimates indicate that gout currently affects more than 8 million patients in the United States alone.

The dissenting committee members questioned whether the benefit of lesinurad over other gout medications was significant enough to preclude safety concerns. The main areas of concern are potential cardiovascular and renal risks that could be associated with the drug.

All 10 of the committee members who voted for approval urged the FDA to ask the drug’s manufacturer, AstraZeneca, for post-launch studies that gauge long-term safety and effectiveness. (The drug was developed by Ardea Biosciences, which was acquired by AstraZeneca in 2012).

If approved, lesinurad will be the first selective uric acid reabsorption inhibitor, or SURI, available in the US.

American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) guidelines recommend that uric acid levels reach a target level of <6.0mg/dL (360 µmol/L). Clinical trials of patients taking first-line therapy show that as many as 25% don’t reach that target level. For patients who cannot reach the target levels, adding an agent that increases uric acid excretion may lead to substantial benefit.