Ipsen (PARIS, France), an international specialty pharmaceutical group, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) adopted a positive opinion for Adenuric^® (febuxostat) 80 mg and 120 mg tablets to treat chronic hyperuricemia for conditions in which urate deposition has already occurred (including a history/presence of tophus and/or gouty arthritis). The CHMP granted marketing authorization to be forwarded to the European Commission for final marketing approval, which typically occurs within 60 to 90 days. Febuxostat will become the first major treatment alternative for chronic hyperuricemia available to gout patients since 1964.

The drug has been shown to reduce serum urate acid (sUA). The most common side effects are liver function abnormalities, diarrhea, headache, nausea, and rash. In clinical trials, serious cardiovascular adverse events were the main safety concern. A pharmacovigilance plan for the drug, as for all medicinal products approved by the European Commission, will be implemented as part of the marketing authorization. The detailed recommendations for the use of febuxostat will be described in the Summary of Product Characteristics, to be made available after the medication receives European Commission marketing authorization and its price is agreed. Febuxostat will be marketed by Ipsen in France under the brand name Adenuric. Outside France, the commercialization of the drug will be partnered.

The EU submission included 2 of the largest industry sponsored studies to date studying treatment of chronic gout patients. Per EULAR (European League Against Rheumatism) guidelines, the goal of chronic gout treatment is to reduce and maintain sUA levels <6 mg/dL. Febuxostat, known as TMX-67 and owned by Teijin Pharma Ltd (Tokyo), is an oral, once-daily medication. As a novel nonpurine, selective inhibitor of xanthine oxidase, the drug demonstrated superior ability in patients to lower and maintain sUA levels <6 mg/dl compared with conventionally used doses of allopurinol (febuxostat 80 mg and 120 mg: 51% and 63%, respectively, vs allopurinol 22%). In addition, one phase III study showed that gout patients with mild-to-moderate renal impairment (serum creatinine >1.5 mg/dL-2 mg/dL) had response rates of 44% and 45%, respectively, with febuxostat 80 mg and 120 mg.

In Europe, febuxostat is licensed to Ipsen from Teijin Pharma, the parent company of Teijin Group's pharmaceutical and home healthcare business. In 2003, the 2 companies entered into a partnership covering Teijin Pharma’s development and subsequent commercialization (in Japan) of 4 Ipsen products, and Ipsen’s development and marketing (in the EU and Russia) of febuxostat.