British-Swedish drugmaker AstraZeneca has received approval from European Medicines Agency (EMA) for its lesinurad 200mg tablets to treat gout patients.
Gout is a chronic and debilitating form of inflammatory arthritis, and is caused by a metabolic disorder hyperuricaemia that leads to the deposition of crystals in musculoskeletal structures including joints, in the kidneys, and in other tissues.
EMA approved marketing authorisation application (MAA) for lesinurad, which is a selective uric acid reabsorption inhibitor (SURI) developed to treat hyperuricaemia in combination with xanthine oxidase (XO) inhibitors allopurinol or febuxostat in gout patients when additional therapy is warranted.
The company submitted a MAA based on data from the Clear1, Clear2 and Crystal pivotal Phase III combination therapy studies.
Clear1 and Clear2 were 12-month, multicentre, randomised and placebo-controlled trials, which assessed the efficacy and safety of a once daily dose of lesinurad in combination with allopurinol against allopurinol alone, in symptomatic gout patients not achieving target serum uric acid (sUA) levels on their current allopurinol therapy.
The 12-month, multicentre, randomised and placebo-controlled Crystal trial assessed efficacy and safety of a once daily dose of lesinurad in combination with febuxostat, compared to febuxostat alone in gout patients with tophi.
AstraZeneca’s subsidiary Ardea Biosciences carried out Clear1, Clear2 and Crystal trials.
AstraZeneca noted that between 40%-80% of patients do not achieve recommended serum urate (sUA) goals with the current standard of care of an XO inhibitor alone. XO inhibitors comprising allopurinol and febuxostat reduce the production of uric acid.
Image: AstraZeneca’s R&D Site in Mölndal, Sweden. Photo: courtesy of Erik031.