European Commission approves marketing for AstraZeneca's new gout treatment
Zurampic (lesinurad), a product of pharmaceutical company AstraZeneca, has been approved by the European Commission (EC) for marketing. This approval includes all EU nations, as well as Iceland, Norway and Lichtenstein.
Zurampic is an oral selective uric acid reabsorption inhibitor (SURI) indicated for treatment of gout in combination with a xanthine oxidase inhibitor (XOI) for adult patients who have not reached their serum uric acid (sUA) level targets when treated with an XOI alone.
Gout is a type of inflammatory arthritis caused by sUA. Millions of people worldwide have been diagnosed with the condition.
Zurampic works by blocking the urate transporter URAT1, which commonly causes the reabsorption of uric acid by the kidneys. Zurampic increases uric acid excretion, decreasing sUA.
"There has been limited therapy innovation in gout over the last 50 years," Sean Bohen, chief medical officer at AstraZeneca, said. "With the approval of Zurampic, we are pleased to offer a new treatment option for the many patients who are suffering from the effects of gout and who are not reaching the recommended serum uric acid treatment targets with the current standard of care."
The next step toward EU approval is a Non-Interventional Post-Authorization Safety Study (PASS), which will assess the drug's cardiovascular safety. AstraZeneca will also conduct a renal safety and effectiveness study.
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