CHMP ISSUES POSITIVE OPINION ON LESINURAD FOR GOUT
AstraZeneca today announced that the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion
recommending the marketing authorisation of lesinurad 200mg tablets. Lesinurad,
in combination with a xanthine oxidase inhibitor (XOI), is recommended for the
adjunctive treatment of hyperuricaemia in adult gout patients (with or without
tophi) who have not achieved target serum uric acid levels (sUA) with an
adequate dose of a XOI alone.
The CHMP’s positive opinion on lesinurad will now be reviewed by the European
Commission (EC), which has the authority to approve medicines for the European
Union (EU). The final decision will be applicable to all 28 EU member countries
plus Iceland, Norway and Liechtenstein. AstraZeneca anticipates a final decision
by the EC in the first quarter of 2016. If approved, lesinurad will be the first
selective uric acid reabsorption inhibitor (SURI) to treat patients with
inadequately controlled gout in Europe.
Lesinurad is also under review in the United States. On 23 October 2015, the US
Food and Drug Administration’s Arthritis Advisory Committee recommended the
approval of lesinurad 200mg tablets for the treatment of hyperuricemia
associated with gout, in combination with an XOI. The Prescription Drug User Fee
Act (PDUFA) target goal date is 29 December 2015.
Gout is a serious and debilitating form of inflammatory arthritis caused by
hyperuricemia (elevated sUA). It affects millions of patients, 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, developed by Ardea Biosciences, a member of the AstraZeneca Group, is
a SURI that 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 sUA.
About Lesinurad
If approved, lesinurad will be the first selective uric acid reabsorption
inhibitor (SURI) in the EU. 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 (OAT) 4
a uric acid transporter involved in diuretic-induced hyperuricemia. In addition,
in people, lesinurad does not inhibit OAT1 and OAT3, which are drug transporters
in the kidney associated with drug-drug interactions.
About Hyperuricemia and Gout
Gout is a serious, chronic, progressive, and debilitating form of inflammatory
arthritis that affects more than 15.8 million people in major markets.* The
underlying cause of gout is hyperuricemia (elevated 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 to the target level
of <6.0mg/dL (360 µmol/L) as recommended by both the American College of
Rheumatology (ACR) and the European League Against Rheumatism (EULAR). In those
with greater disease severity and urate burden, such as those with tophi,
guidelines recommend lowering sUA to <5.0 mg/dL (300 µmol/L) to achieve better
disease control.
Among patients treated in clinical trials, less than 50% of patients on
allopurinol 300mg reached sUA target levels <6.0mg/dL (360 µmol/L). For patients
who cannot reach target on an XOI alone, the current ACR and EULAR guidelines
recommend adding an agent that increases uric acid excretion.
*Major markets include the United States, France, Germany, Italy, Spain, the
United Kingdom and Japan
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 (ULT) with
xanthine oxidase inhibitors. RDEA3170 is our lead investigational ULT in Asia
and is currently entering a Phase IIb trial worldwide.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that
focuses on the discovery, development and commercialisation of prescription
medicines, primarily for the treatment of diseases in three main therapy areas -
respiratory, inflammation, autoimmune disease (RIA), cardiovascular and
metabolic disease (CVMD) and oncology - as well as in infection and
neuroscience. AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more information
please visit: www.astrazeneca.com
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Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and
Metabolic Disease,
ING - Infection, Neuroscience and Gastrointestinal
18 December 2015
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