AstraZeneca files marketing authorization application with EMA for lesinurad

22 January 2015

The European Medicines Agency has accepted the marketing authorization application by AstraZeneca (LSE: AZN) for lesinurad.

Lesinurad is a selective uric acid reabsorption inhibitor developed for the chronic treatment of hyperuricemia in combination with the xanthine oxidase inhibitors allopurinol or febuxostat in gout patients, when additional therapy is warranted.

The filing is based on the CLEAR1, CLEAR2 and CRYSTAL Phase III study results. CLEAR1 and CLEAR2 evaluated the efficacy and safety of a once daily dose of lesinurad in combination with allopurinol versus allopurinol alone, in symptomatic gout patients not achieving target serum uric acid (sUA) levels on their current allopurinol therapy. CRYSTAL was a 12-month, multicentre, randomised, placebo-controlled study that evaluated the efficacy and safety of a once daily dose of lesinurad in combination with febuxostat compared to febuxostat alone in gout patients with tophi.

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