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EMA accepts AstraZeneca’s MAA for gout treatment lesinurad

The European Medicines Agency has accepted AstraZeneca's marketing authorisation application (MAA) for lesinurad 200mg tablets for the chronic treatment of hyperuricaemia in combination with xanthine oxidase (XO) inhibitors allopurinol or febuxostat in gout patients when additional therapy is warranted.

AstraZeneca Headquarters London

Lesinurad is a selective uric acid reabsorption inhibitor (SURI) that works by inhibiting the uric acid transporter URAT1 in the kidney, thereby increasing uric acid excretion resulting in lower serum uric acid (sUA).

Currently, lesinurad is being studied as an investigational agent for the treatment of gout.

The submission was based on data from the CLEAR1, CLEAR2 and CRYSTAL pivotal Phase III combination therapy trials.

The CLEAR1 and CLEAR2 were 12-month, multicentre, randomised, placebo-controlled trials, which assessed 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.

The 12-month, multicenter, randomized, placebo-controlled CRYSTAL trial 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.

Ardea Biosciences, a member of the AstraZeneca Group, was responsible for conducting the CLEAR1, CLEAR2 and CRYSTAL trials.


Image: AstraZeneca headquarters in London, UK. Photo: courtesy of AstraZeneca plc.