AZ's gout drug Zurampic gains EU approval

The European Commission approved an MAA for Zurampic lesinurad from AstraZeneca plc (LSE:AZN; NYSE:AZN) in combination with a xanthine oxidase inhibitor (XOI) to treat hyperuricemia in adults with gout. The company said it will conduct a postapproval cardiovascular safety study and a renal efficacy and safety study of the drug.

FDA approved Zurampic in December, and required a postmarketing renal and CV study. The drug's U.S. label has a boxed warning noting risk of renal failure (see BioCentury Extra, Dec. 22, 2015). ...