Novartis (BASEL, Switzerland) announced that PrexigeR (lumiracoxib), an oral selective COX-2 inhibitor anti-inflammatory drug, has been cleared for approval in the European Union (EU) as a new treatment option for patients suffering from osteoarthritis (OA). Prexige has successfully completed the Mutual Recognition Procedure (MRP) in the European Union, and all 26 EU member states have agreed to issue national approval. Initial approval for Prexige was granted in the UK, where it has been available since December 2005.
 
In addition to the EU, 25 other countries have already approved Prexige, including recent approval in Canada. It is expected to become available in European countries during 2007 and 2008. Novartis plans to resubmit Prexige for US approval in 2007.

Prexige will be available in 100 mg tablets (once daily dosing) and indicated for the symptomatic relief in the treatment of knee and hip OA. The decision was based on data from clinical trials involving 34,000 patients - the largest-ever body of evidence supporting the launch of an anti-inflammatory agent.

Prexige differs from other selective COX-2 inhibitors by targeting the site of pain, rapidly clearing from the blood, and being quickly absorbed in the inflamed joint. Prexige offers similar pain relief to the commonly used OA medication celecoxib. However it has demonstrated a superior gastrointestinal safety profile to traditional nonsteroidal anti-inflammatory drugs (NSAIDs).

The TARGET study, the largest published 1-year study of gastrointestinal safety outcomes in OA patients to date (N = 18,325), has demonstrated that Prexige significantly reduced the incidence of serious upper GI complications by 79% compared with the NSAIDs ibuprofen and naproxen in patients not taking aspirin. In further subanalyses, Prexige reduced the risk of ulcer complications within the first month of use and offered significant benefit compared to naproxen in older patients at greater gastrointestinal risk. Compared to NSAIDs, Prexige demonstrated a similar cardiovascular safety profile and a significantly smaller effect on blood pressure.

—A. Techman

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