NOVARTIS' OSTEOARTHRITIS DRUG APPROVED IN THE EU

Swiss drugmaker Novartis announced today that Prexige, a selective COX-2 inhibitor anti-inflammatory drug, has been cleared for approval in the European Union (EU) as a new treatment option for patients with osteoarthritis. Prexige (lumiracoxib) has successfully completed the Mutual Recognition Procedure in the European Union, and all 26 EU member states have agreed to issue national approval.

In addition to the EU, Prexige is already approved in more than 25 countries, including the approval also granted today in Canada. It is expected to become available in European countries during 2007 and 2008. Novartis plans to resubmit the drug for U.S. approval in 2007.

Prexige will be available in 100-mg tablets (for once-daily dosing) and indicated for the symptomatic relief in the treatment of knee and hip osteoarthritis. 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, Novartis said in a release.

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, according to Novartis. Prexige offers similar pain relief to the commonly used osteoarthritis medication celecoxib; however it has demonstrated a superior gastrointestinal safety profile to traditional non-steroidal anti-inflammatory drugs (NSAIDs), the company said.

Furthermore, compared to NSAIDs, Prexige demonstrated a similar cardiovascular safety profile and a significantly smaller effect on blood pressure, according to Novartis.