EMA accepts marketing authorization application for lesinurad

AstraZeneca announced recently that the European Medicines Agency has accepted its marketing authorization application for lesinurad 200-mg tablets.

The selective uric acid reuptake inhibitor was developed for the treatment of chronic hyperuricemia as an add-on therapy to allopurinol or febuxostat, two xanthine oxidase inhibitors, in patients with gout who require additional therapy, according to a company press release.

AstraZeneca filed the application based on data from a series of three phase 3 combination therapy studies. The 12-month, multicenter, randomized, placebo-controlled CLEAR1 and CLEAR2 studies evaluated the efficacy and safety of once-daily lesinurad combined with allopurinol vs. allopurinol alone in patients with systematic gout who did not achieve target serum uric acid (sUA) levels on their current therapy. The 12-month, multicenter, randomized, placebo-controlled study. CRYSTAL, also a 12-month, multicenter, randomized, placebo-controlled study, evaluated safety and efficacy of once-daily lesinurad combined with febuxostat vs. febuxostat alone in patients with gout and topli.

In the CLEAR1 and 2 studies, lesinurad 200 mg and 400 mg combined with allopurinol met the studies’ primary endpoints, with a statistically significantly higher proportion of patients reaching the target sUA goal of less than 6 mg/dL by month 6 compared with allopurinol alone.

CRYSTRAL also met the study’s primary endpoint with lesinurad 400 combined with febuxostat, with a statistically significantly higher number of patients achieving target sUA goal of less than 5 mg/dL compared with febuxostat alone, according to a separate release.

Lesinurad is intended to inhibit the uric acid transporter, URAT1, in the kidney, resulting in the excretion of uric acid through the kidneys and the lowering of sUA. Through combined therapy with lesinurad and an XO inhibitor, significantly more patients are able to achieve and maintain target treatment goals and control their disease, according to the release.

Adverse events in the studies included upper-respiratory tract infection, nasopharyngitis and back pain.

“There is a significant unmet need, with 40% to 70% of gout patients not reaching target levels of serum uric acid with the current standard of care,” Briggs Morrison, executive vice president of Global Medicines Development and chief medical officer for AstraZeneca, said in the press release. “Data indicate that combination therapy with lesinurad may be a potential treatment option for gout patients.”

Reference: www.astrazeneca.com.