FDA approves lesinurad in combo with xanthine oxidase inhibitor to lower uric acid levels

The FDA has approved the use of lesinurad for use in combination with a xanthine oxidase inhibitor to treat high blood uric acid levels associated with gout.

The decision to approve the combination treatment with lesinurad (Zurampic, AstraZeneca) follows a positive recommendation from the FDA’s Arthritis Advisory Committee in October.

“Controlling hyperuricemia is critical to the long-term treatment of gout,” Badrul Chowdhury, MD, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Zurampic provides a new treatment option for the millions of people who may develop gout over their lifetimes.”

Lesinurad inhibits the function of transporter proteins associated with the reabsorption of uric acid in the kidneys and improves the ability of the kidneys to excrete uric acid.

Three randomized, placebo-controlled studies with 1,537 participants for up to 12 months were conducted with lesinurad in combination with a xanthine oxidase inhibitor prior to the approval. Compared to placebo, participants who received lesinurad were more likely to have reductions in serum uric acid.

A boxed warning with safety information related to a risk for acute renal failure will be included in the packaging. Other adverse events included headache, influenza, increased levels of blood creatinine and gastroesophageal reflux diseases.

Reference: www.fda.gov