Novartis' painkiller Prexige cleared in EU

Swiss drug major Novartis' Prexige (lumiracoxib) has been approved in the European Union as a new treatment option for patients suffering from osteoarthritis, the most common form of arthritis and a leading cause of chronic pain. The oral selective COX-2 inhibitor has successfully completed the Mutual Recognition Procedure in the EU, and all 26 member states have agreed to issue national approval.

Initial clearance for the drug was granted in the UK, where it has been available since December 2005. In addition to the EU, Prexige is already approved in more than 25 countries, including recently in Canada. Novartis expects it to become available in European countries during 2007 and 2008 and plans to resubmit Prexige for US approval in 2007. The firm noted that the agent will be available in 100mg tablets (once daily dosing) for symptomatic relief in the treatment of knee and hip osteoarthritis. The decision was based on data from clinical trials involving approximately 34,000 patients.