AZ's Zurampic gains FDA approval for gout

FDA approved Zurampic lesinurad from AstraZeneca plc (LSE:AZN; NYSE:AZN) in combination with a xanthine oxidase inhibitor to treat hyperuricemia associated with gout. The approval came a week ahead of the drug's Dec. 29 PDUFA date.

Zurampic has a boxed warning noting risk of renal failure. FDA also is requiring a postmarketing study of the drug's renal and cardiovascular safety. Zurampic is a selective solute carrier family 22 organic anion urate transporter member 12 ( SLC22A12; URAT1) inhibitor. ...