Phase III subanalysis of Zurampic (lesinurad) shows efficacy and safety in gout- AstraZeneca

AstraZeneca announced positive subanalysis data of the Phase III Zurampic (lesinurad) studies (CLEAR1, CLEAR2 and CRYSTAL) for the treatment of hyperuricaemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI). The results demonstrated a consistent efficacy and safety profile in patients with normal renal function, as well as patients with mild to moderate renal impairment. In CLEAR1, CLEAR2 and CRYSTAL efficacy and safety endpoints from these pivotal Phase III trials were analysed in patients with normal renal function (eCrCl at least 90 mL/min), patients with mild or moderate renal impairment (less than 90 ml/min) and specifically those with moderate renal impairment (less than 60 ml/min). Patients with severe renal impairment (less than 30 ml/min) were not studied.

Lesinurad 200 mg in combination with an XOI resulted in consistent efficacy with a similar proportion of patients achieving sUA targets across these renal function categories. In addition, safety findings were consistent between treatment groups across all renal function categories. Renal-related adverse events increased with decreasing renal function irrespective of lesinurad treatment, with no notable treatment group differences within renal function categories.This subanalysis was presented at the American College of Rheumatology (ACR) 2015.

Comment: Current treatments are limited to the 50-year-old generic allopurinol and Takeda/Ipsen/Menarini's febuxostat, a drug approved in 2009 that does not work in every patient. AstraZeneca filed lesinurad in the EU in January 2015 and is FDA-committee recommended in the US.