FDA approves AstraZeneca’s gout drug Zurampic
pharmafile | December 23, 2015 | News story | Sales and Marketing | AstraZeneca, FDA, Zurampic, gout, lensinurad
The US FDA has approved AstraZeneca’s Zurampic to treat high levels of uric acid in the blood.
The drug is approved for hyperuricaemia 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.
Gout is a painful form of arthritis caused by excess uric acid build-up in the body, and usually appears first as redness, soreness, and swelling in the big toe. Uric acid usually dissolves in the blood then passes through the kidneys and out of the body in urine, but can build up in the blood in a condition called hyperuricaemia. People with the condition may develop gout if uric acid forms crystals in the body.
Zurampic (lesinurad) works by helping the kidney excrete uric acid 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 randomised, placebo-controlled studies of 1,537 participants in combination with a XOI. In the trials, patients treated with Zurampic in combination with a XOI experienced reduced blood uric acid levels compared to placebo. The most common adverse reactions in clinical trials were headache, influenza, increased blood creatinine, and gastroesophageal reflux disease.
“Controlling hyperuricemia is critical to the long-term treatment of gout,” says Badrul Chowdhury, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Centre for Drug Evaluation and Research. “Zurampic provides a new treatment option for the millions of people who may develop gout over their lifetimes.”
Zurampic has a boxed warning detailing the risk for acute kidney failure, which is more common when used without an XOI and with higher-than-approved doses of Zurampic.
The Agency originally recommended the drug’s approval in October, despite safety concerns, and recommended the lower dose of 200mg. The FDA is also requiring a postmarketing study to further evaluate the renal and cardiovascular safety of Zurampic. The EMA’s Committee for Medicinal Products for Human Use has also recommended the treatment in Europe.
Joel Levy
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