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Lesinurad gains EU approval for hyperuricemia in patients with gout
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AstraZeneca announced marketing authorization for lesinurad has been granted by the European Commission in combination with a xanthine oxidase inhibitor for the adjunctive treatment of hyperuricemia in adult patients with gout, according to a company press release.
The indication for treatment with lesinurad (Zurampic, AstraZeneca) is for patients who have had an inadequate response to xanthine oxidase inhibitors and have not met serum uric acid target levels. Lesinurad is a selective, uric acid re-absorption inhibitor and is believed to inhibit URAT1, a urate transporter responsible for renal re-absorption of most uric acid. Lesinurad may lower serum uric acid by increasing the excretion of uric acid through the inhibition of URAT1, according to the release.
“There has been limited therapy innovation in gout over the last 50 years,” Sean Bohen, executive vice president of Global Medicines Development and chief medical officer at AstraZeneca, said in the release. “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 approval follows three phase 3 trials with 1,537 patients with gout. AstraZeneca is required to conduct a non-interventional post-authorization safety study to assess the potential cardiovascular risks lesinurad may present, particularly in patients with a history of cardiovascular events. A renal study also will be conducted in patients with creatinine clearance of 30 mL/min to 45 mL/min in the European Union.
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