FDA Approves Zurampic To Treat Gout

The FDA today approved lesinurad (Zurampic, AstraZeneca Pharmaceuticals) to treat hyperuricemia associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI), a type of drug that reduces the production of uric acid in the body.

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 from the breakdown of 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. Hyperuricemia occurs when the body increases the amount of uric acid it makes, the kidneys do not eliminate enough of it 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.

Lesinurad 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 of lesinurad were evaluated in three randomized, placebo-controlled studies in combination with an XOI involving 1,537 participants for up to 12 months. Participants treated with lesinurad in combination with an XOI experienced reduced serum uric acid levels compared with placebo.

The most common adverse reactions in clinical trials were headache, influenza, increased blood creatinine and gastroesophageal reflux disease.
Zurampic has a boxed warning that provides important safety information for health care professionals, including a risk for acute kidney failure, which is more common when used without an XOI and with higher than approved doses of Zurampic.
The FDA is also requiring a postmarketing study to further evaluate the renal and cardiovascular safety of Zurampic.

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

See More At: http://www.pharmacypracticenews.com/ViewArticle.aspx?d=New%2bDrug%2bApprovals&d_id=585&i=December+2015&i_id=1273&a_id=34646

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