AstraZeneca gains EU approval for Zurampic and expanded use of Brilique

The European Commission (EC) has granted marketing authorization for Zurampic (lesinurad) 200mg in combination with a xanthine oxidase inhibitor (XOI) for the adjunctive treatment of hyperuricemia in adult gout patients (with or without tophi) who have not achieved target serum uric acid (sUA) levels with an adequate dose of an XOI alone, Anglo-Swedish pharma major AstraZeneca (LSE: AZN) announced today.

Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, said: “There has been limited therapy innovation in gout over the last 50 years. 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.”

As part of the European Union approval, AstraZeneca will conduct a non-interventional post-authorization safety study (PASS) to investigate the cardiovascular safety profile (mainly in patients with history of cardiovascular disorder) exposed to Zurampic. In addition to the PASS, we have agreed to conduct an EU renal study to assess efficacy and safety in patients with creatinine clearance of 30-45mL/min.