Source: DGNews  |  Posted 3 years ago

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 >1.5 to ≤2.0 mg/dL) had a response rate of 44% with febuxostat 80 mg and 45% with febuxostat 120 mg.

Febuxostat, an oral, once-daily medication, is a novel, nonpurine, selective inhibitor of xanthine oxidase studied for its effects on lowering levels of sUA in patients with gout. Febuxostat works quickly to allow retesting of the serum uric acid after 2 weeks. The therapeutic target is to decrease and maintain serum uric acid levels below 6 mg/dL. Gout flare prophylaxis of at least 6 months is recommended at initiation of treatment with febuxostat.

SOURCE: Ipsen