European Medicines Agency Accepts MAA for Gout Drug

the Clinical Pain Advisor take:

The European Medicines Agency has accepted the Marketing Authorization Application (MAA) for lesinurad 200 mg tablets.

According to a press release from AstraZeneca, lesinurad is a selective uric acid reabsorption inhibitor (SURI) developed for the chronic treatment of hyperuricaemia in combination with xanthine oxidase (XO) inhibitors allopurinol or febuxostat in gout patients when additional therapy is warranted.

The MAA filing was based on data from three clinical trisl - the CLEAR1, CLEAR2 and CRYSTAL Phase 3 studies. CLEAR1 and CLEAR2 were 12-month, randomized placebo-controlled studies that 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 year-long randomized, 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.

The combined therapies of lesinurad and an XO inhibitor provides a dual mechanism approach targeting both excretion and production of uric acid, according to the study results, which were published by Ardea Biosciences, a member of the AstraZeneca Group.