FDA approves Zurampic(lesinurad) with a xanthine oxidase inhibitor to treat hyperuricemia associated with gout- AstraZeneca.

The FDA has approved Zurampic (lesinurad) from AstraZeneca, to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI), a type of drug approved to reduce the production of uric acid in the body.Zurampic works by helping the kidney excrete uric acid. It does this by inhibiting the function of transporter proteins involved in uric acid reabsorption in the kidney.

The safety and efficacy for Zurampic were evaluated in three randomized, placebo-controlled studies in combination with a XOI involving 1,537 participants for up to 12 months. Participants treated with Zurampic in combination with a XOI experienced reduced serum uric acid levels (sUA) compared to placebo.Zurampic has a boxed warning that provides important safety information for health care professionals, including the risk for acute kidney (renal) failure, which is more common when used without an XOI and with higher than approved doses of Zurampic. The FDA is also requiring a post-marketing study to further evaluate the renal and cardiovascular safety of Zurampic.

Comment: Between 40 to 80% of patients do not achieve recommended sUA goals with the current standard of care of an XO inhibitor alone. XO inhibitors including allopurinol and febuxostat reduce the production of uric acid. Lesinurad works by inhibiting the uric acid transporter URAT1 in the kidney, thereby increasing uric acid excretion resulting in lower sUA. Combination therapy with lesinurad and an XO inhibitor provides a dual mechanism approach targeting both excretion and production of uric acid which effectively lowers sUA and enables significantly more patients to achieve and maintain target treatment goals to control their disease.