AstraZeneca announced that the US Food and Drug Administration (FDA) has approved
ZURAMPIC® (lesinurad) 200mg tablets in combination with a xanthine
oxidase inhibitor (XOI) for the treatment of hyperuricemia associated
with gout in patients who have not achieved target serum uric acid (sUA)
levels with an XOI alone.
ZURAMPIC inhibits the urate transporter, URAT1, which is responsible
for the majority of the renal reabsorption of uric acid. By inhibiting
URAT1, ZURAMPIC increases uric acid excretion and thereby lowers sUA.
In combination with the current standard of care, XOIs allopurinol or
febuxostat, ZURAMPIC provides a dual mechanism of action to increase
excretion and decrease production of uric acid, enabling more patients
with inadequately controlled gout to achieve target treatment goals.
The FDA approval is based on data from three pivotal Phase III
studies, CLEAR1, CLEAR2 and CRYSTAL, which represent the largest
clinical trial data set of gout patients (n=1,537 total) treated with
combination urate lowering therapy.
Gout is a serious and debilitating form of inflammatory arthritis
caused by hyperuricemia (elevated sUA). It affects millions of people
around the globe, many of whom do not reach recommended sUA treatment
goals on XOIs, which decrease production of uric acid. For those
inadequately controlled patients, the addition of a urate-lowering
therapy to increase excretion of uric acid may help them achieve
treatment goals.
