The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for lesinurad (Zurampic, AstraZeneca AB) for the treatment of hyperuricemia in combination with a xanthine oxidase inhibitor in adults with gout.
Lesinurad is a selective uric acid reabsorption inhibitor that also increases uric acid secretion, lowering uric acid levels. It will be available as film-coated tablets containing 200 mg of the drug.
"AstraZeneca anticipates a final decision by the EC in the first quarter of 2016. If approved, lesinurad will be the first selective uric acid reabsorption inhibitor (SURI) to treat patients with inadequately controlled gout in Europe," according to a company news release.
An advisory committee of the US Food and Drug Administration recommended approval of lesinurad on October 23, 2015. The agency is expected to make a decision later this month.
In clinical trials, the most frequently reported adverse effects were headache, influenza, increased serum creatinine, and gastroesophageal reflux.
The full indication for lesinurad is, "Zurampic, in combination with a xanthine oxidase inhibitor, is indicated in adults for the adjunctive treatment of hyperuricemia in gout patients (with or without tophi) who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor alone."
The European public assessment report will publish a summary of product characteristics, which will provide detailed recommendations for the use of lesinurad. The summary of product characteristics will be available in all official European Union languages after the European Commission grants marketing authorization.
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Cite this: CHMP Recommends Lesinurad (Zurampic) for Gout - Medscape - Dec 18, 2015.