Lesinurad filed at EMA for treatment of Hyperuricaemia( Gout)- AstraZeneca

AstraZeneca announced the European Medicines Agency has accepted the Marketing Authorisation Application (MAA) for lesinurad 200mg tablets. 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 the CLEAR 1, CLEAR 2 and CRYSTAL pivotal Phase III combination therapy studies. CLEAR 1 and CLEAR 2 were 12-month, multicentre, randomised, 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 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 (deposits of uric acid crystals in joints and skin).

Between 40 to 80% of patients do not achieve recommended sUA goals with the current standard of care of an XO inhibitor alone. XO inhibitors including allopurinol and febuxostat reduce the production of uric acid. Lesinurad works by inhibiting the uric acid transporter URAT1 in the kidney, thereby increasing uric acid excretion resulting in lower sUA. Combination therapy with lesinurad and an XO inhibitor provides a dual mechanism approach targeting both excretion and production of uric acid which effectively lowers sUA and enables significantly more patients to achieve and maintain target treatment goals to control their disease.