Febuxostat Approved in Europe for the Treatment of Chronic

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Febuxostat Approved in Europe for the Treatment of Chronic Hyperuricaemia in Patients With Gout

PARIS -- May 6, 2008 -- The European Commission has granted marketing authorisation for febuxostat (Adenuric) for the treatment of chronic hyperuricaemia in gout. Febuxostat is the first major treatment alternative for gout in more than 40 years.

Recent surveys confirm that management of gout is often suboptimal, with less than half of patients receiving appropriate lifestyle advice or urate-lowering treatment, said Michael Doherty, MD, Professor of Rheumatology, University of Nottingham, Nottingham, United Kingdom, and Co-Chair of the 2006 European League Against Rheumatism (EULAR) Task Force for the Recommendations on Diagnosis and Management of Gout.

Recent European EULAR recommendations emphasise the aim of 'cure' by lowering serum urate levels below the saturation point for crystal formation. For some patients, the existing urate-lowering therapies have limitations in terms of suitability or side effects. The availability of a new effective therapy that allows the therapeutic target to be achieved will improve the physicians' armamentarium and ultimately benefit the population of patients with gout, said Prof. Doherty.

Febuxostat 80- and 120-mg tablets are indicated for the treatment of chronic hyperuricaemia for conditions in which urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat will be marketed by Ipsen in France. Outside France, the commercialisation of the product will be partnered.

The EU submission included 2 of the largest industry-sponsored studies to date studying treatment of patients with chronic gout. The goal of chronic gout treatment is, according to EULAR guidelines, to reduce and maintain serum uric acid (sUA) levels below 6 mg/dL (357 mcmol/L). Febuxostat demonstrated superior ability to lower and maintain serum uric acid levels below 6 mg/dL compared with conventionally used doses of allopurinol (febuxostat 80 mg/dL, 51%; febuxostat 120 mg, 63%; allopurinol, 22%). In addition, one phase 3 study showed that gout patients with mild to moderate renal impairment (serum creatinine

After 20 years of successful clinical practice, Professor Wu Yingping Rheumatism Shizhibuyi engaged in the research results obtained on national science and technology advancement awards, the development of the rule, a treatment for rheumatoid arthritis, inflammation drugs and strong ridge Preparation, stubborn Bi Capsule , a treatment for osteoporosis drugs and preparation methods, hand-like holographic clinics have been national patents. The creation of the main, object-free transfer, foreign rule and function of the five elements ; Jire, cut off, Qingyuan, fundamental change, Fuzheng the five levels ; oxygen therapy for treatment-free, calcium acid therapy, drugs Bath therapy, physical therapy as one of the unique method of governance Bi. Professor Wu Yingping treatment of rheumatoid bone disease has become a collection of drug treatment, psychological treatment, physical therapy, nutrition Conditioning, functional training in one of the British-bone disease treatment of rheumatoid system , according to clinical observation statistics, the use of this A system for rheumatoid bone disease, its effective rate was 98.0 percent, the cure rate was 55.8 percent, for domestic and the United States, Japan, Thailand and other countries and Hong Kong, Macao and Taiwan regions of the more than 520,000 cases of rheumatism, like the wind Wetlands disease, ankylosing spondylitis, osteonecrosis of the femoral head, lumbar disc herniation, such as rheumatism patients with gout lifted the illness, the combination of Western medicine in the treatment of rheumatism in the area of a breakthrough has been made. Industry experts have been called green combination therapy, she was also known as the modern woman Hua.

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Additional information :

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