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FDA Oks Zurampic To Treat High Blood Uric Acid Levels Associated With Gout

The U.S. Food and Drug Administration said it approved AstraZeneca plc.'s (AZN.L,AZN) Zurampic or lesinurad to treat high levels of uric acid in the blood or hyperuricemia associated with gout, when used in combination with a xanthine oxidase inhibitor or XOI, a type of drug approved to reduce the production of uric acid in the body.

The FDA also requires a postmarketing study to further evaluate the renal and cardiovascular safety of Zurampic.

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.

Gout is a painful form of arthritis caused by the buildup of too much uric acid in the body, and usually appears first as redness, soreness, and swelling in the big toe. Uric acid in the blood is produced by the breakdown of substances called purines, which are found in all the body's tissues. Uric acid usually dissolves in the blood then passes through the kidneys and out of the body in urine.

Uric acid can build up in the blood, a condition called hyperuricemia. This occurs when the body increases the amount of uric acid it makes, the kidneys do not get rid of enough uric acid, or a person eats too many foods high in purines. Most people with hyperuricemia do not develop gout, but if uric acid forms crystals in the body, gout can develop.

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 most common adverse reactions in clinical trials were headache, influenza, increased blood creatinine, and gastroesophageal reflux disease.

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