FDA Arthritis Committee Recommends Lesinurad Approval
AstraZeneca announced that the Food and Drug Administration (FDA) Arthritis Advisory Committee (AAC) has recommended the approval of lesinurad 200mg tablets for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI). The AAC voted 10-4 in favor of approval after reviewing safety and efficacy data from the Phase 3 combination therapy program trials.
If approved, lesinurad will be the first selective uric acid reabsorption inhibitor, or SURI, in the United States. Lesinurad inhibits URAT1, a urate transporter, 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.
The FDA is not bound by the Advisory Committee's recommendation but takes it into consideration when reviewing the drug application. The Prescription Drug User Fee Act (PDUFA) target date for lesinurad is December 29, 2015.
For more information visit AstraZeneca-US.com.