AstraZeneca today announced that the US Food and Drug
Administration’s (FDA) Arthritis Advisory Committee (AAC) voted 10 to 4
to recommend the approval of lesinurad 200mg tablets for the treatment
of hyperuricemia associated with gout, in combination with a xanthine
oxidase inhibitor (XOI). The AAC reviewed safety and efficacy data from
the pivotal Phase III combination therapy programme trials, representing
the largest clinical trial data set of gout patients treated with
combination urate lowering therapy.
The FDA is not bound by the Advisory Committee’s recommendation but
takes its advice into consideration when reviewing the application for a
potential medicine. The Prescription Drug User Fee Act (PDUFA) target
goal date for lesinurad is 29 December 2015.
If approved, lesinurad will be the first selective uric acid
reabsorption inhibitor, or SURI, in the US. It inhibits the urate
transporter, URAT1, which is responsible for the majority of the renal
reabsorption of uric acid.
Sean Bohen, Executive Vice President of Global Medicines Development
and Chief Medical Officer, AstraZeneca, said: “The Committee’s positive
recommendation for lesinurad is an encouraging step for patients
suffering from the debilitating effects of gout. We look forward to the
outcome of the FDA’s review and the opportunity to provide a new
treatment option that, when combined with a xanthine oxidase inhibitor,
addresses both the under-excretion and over-production of uric acid, the
underlying causes of gout.”
Gout is a serious and debilitating form of inflammatory arthritis
caused by hyperuricemia (elevated serum uric acid (sUA)). Gout affects
millions of Americans, many of whom do not reach recommended sUA
treatment goals on the current standard of care (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.
