Zurampic Approved for Gout

By on December 23, 2015

Zurampic (lesinurad) has been approved by the U.S. Food and Drug Administration to control blood levels of uric acid associated with gout.

Gout, a form of arthritis, commonly emerges as pain, redness and swelling in the big toe. Uric acid normally is a natural waste product that’s passed through the kidneys. But when it builds up in the body, crystals may form and lead to gout.

Zurampic, approved in combination with a second drug called xanthine oxidase, helps the kidneys avoid reabsorbing uric acid, then aids the kidneys in excreting uric acid from the body, the FDA said in a news release.

Zurampic was evaluated in clinical studies involving more than 1,500 people. Those treated with the drug combination saw a drop in uric acid levels, compared to those who took placebos.

The most common side effects of Zurampic included headache, a rise in a blood compound called creatinine, flu and chronic heartburn (gastroesophageal reflux disease).

Zurampic’s label will include a boxed warning of the possibility of kidney failure if it is used without the second drug, or at higher-than-approved doses, the FDA said.

The agency said it ordered Zurampic’s Delaware-based manufacturer AstraZeneca to conduct additional trials to further evaluate the drug’s effects on the kidneys and heart.

More information

The FDA has more about this approval.

Source: HealthDay

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