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.
The FDA has more about this approval.