AstraZeneca, a global, innovation-driven biopharmaceutical business, 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 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.
Lesinurad is also under regulatory review in the European Union and other territories.
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. By inhibiting URAT1, lesinurad increases uric acid excretion and thereby lowers serum uric acid (sUA). Lesinurad also inhibits organic anion transporter (OAT4), a uric acid transporter involved in diuretic-induced hyperuricemia. In addition, in patients, lesinurad does not inhibit OAT1 and OAT3, which are drug transporters in the kidney associated with drug-drug interactions.
If approved, lesinurad in combination with an XOI would provide a dual mechanism of action to increase excretion and decrease production of uric acid enabling more patients with inadequately controlled gout to achieve target treatment goals.