AstraZeneca today announced that the US Food and Drug Administration’s
(FDA) Arthritis Advisory Committee (AAC) voted 10-4 to recommend the
approval of lesinurad 200 mg 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 program 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 December 29, 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, a disease in which
there has been limited treatment innovation over the last 50 years. We
look forward to the outcome of the FDA’s review and the opportunity to
provide a new treatment option that when combined with an XOI 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.
Lesinurad is also under regulatory review in the European Union and
other territories.
NOTES TO EDITORS
About Lesinurad
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. By inhibiting URAT1, lesinurad increases uric
acid excretion and thereby lowers serum uric acid (sUA). Lesinurad also
inhibits organic anion transporter (OAT4) a uric acid transporter
involved in diuretic-induced hyperuricemia. In addition, in patients,
lesinurad does not inhibit OAT1 and OAT3, which are drug transporters in
the kidney associated with drug-drug interactions.
If approved, lesinurad in combination with an XOI would provide 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.
About Hyperuricemia and Gout
Gout is a serious, chronic, progressive, and debilitating form of
inflammatory arthritis. Currently, there are more than 8.3 million
patients suffering from gout in the US. The underlying cause of gout is
hyperuricemia (elevated serum uric acid (sUA)), which leads to the
deposition of crystals primarily in the joints and in other tissues.
This can result in recurrent attacks of inflammatory arthritis and, if
left uncontrolled, could lead to chronic, progressive arthritis, and
tophus (visible deposits of urate crystals) formation.
The goal of sUA lowering treatment is to reduce sUA levels tothe target
level of <6.0 mg/dL as recommended by the American College of
Rheumatology (ACR). To improve signs and symptoms such as tophaceous
gout, the ACR guidelines state that achieving and maintaining sUA levels
<5.0 mg/dL may be required.
Among patients treated in clinical trials, less than 50% of patients on
allopurinol 300 mg reached serum uric acid (sUA) target levels <6.0
mg/dL. This suggests approximately two million gout patients in the US
on urate lowering therapy remain inadequately controlled. For patients
who cannot reach target on an XOI alone, the current ACR guidelines
recommend adding an agent that increases uric acid excretion.
About Ardea Biosciences
Ardea Biosciences, Inc. was acquired by AstraZeneca in June 2012. It is
located in San Diego, California and is a member of the AstraZeneca
Group. Ardea is leading the development of AstraZeneca’s gout portfolio,
including lesinurad and RDEA3170. RDEA3170 is a potent selective uric
acid reabsorption inhibitor (SURI), also intended for use as a
combination urate lowering therapy with xanthine oxidase inhibitors
(XOIs). RDEA3170 is our lead investigational urate lowering therapy
(ULT) in Asia and is currently entering a Phase IIb trial in the US.
About AstraZeneca
AstraZeneca (NYSE: AZN) is a global, innovation-driven biopharmaceutical
business that focuses on the discovery, development and
commercialization of prescription medicines, primarily for the treatment
of cardiovascular, metabolic, respiratory, inflammation, autoimmune,
oncology, infection and neuroscience diseases. AstraZeneca operates in
over 100 countries and its innovative medicines are used by millions of
patients worldwide. For more information please visit: www.astrazeneca-us.com.
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