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Novartis Data Shows ACZ885 for Severe Gouty Arthritis Provided Better Pain Relief and Reduced Risk of New Attacks by Up to 68% vs. Steroid
Date:5/24/2011

gouty arthritis is estimated to be five times more prevalent than rheumatoid arthritis in the US(5,6).  

"We are very excited about these results, which indicate that ACZ885 may become a significant new alternative for gouty arthritis patients where many standard anti-inflammatory treatments are inadequate or inappropriate," said David Epstein, Head of the Pharmaceuticals Division of Novartis. "Novartis is committed to meeting this unmet medical need and to further investigating the potential of ACZ885 in a number of other conditions where interleukin-1 beta may play a role."

Gouty arthritis attacks occur when the body has a strong inflammatory response to uric acid crystals forming in the affected joint, typically of the toe, foot, ankle or knee(7-9). This intense inflammatory response causes the severe pain and other debilitating symptoms associated with gouty arthritis attacks, which can last for a week or more(3,9-11).

Treatments currently available to manage the pain and inflammation of gouty arthritis attacks, such as NSAIDs or colchicine, may be inadequate or inappropriate in patients who have coexisting medical problems(12-14). This poses a significant unmet treatment need in gouty arthritis. In the US alone, more than 95% of patients with gouty arthritis or high uric acid levels (hyperuricemia) have at least one coexisting disease(15), a portion of whom may be unable to take these standard therapies.

Regulatory filings for the use of ACZ885 in gouty arthritis patients with limited treatment options were submitted in the EU in 2010 and in the US, Canada and Switzerland in the first quarter of 2011. ACZ885 is currently approved in the US and other countries for a different disease state.

About the StudiesThe two studies were Phase III, 12-week, randomized, multicenter, double-blind, double dummy, active-controlled studies involving 228 and 226 patients who met the American College of Rheumatology (ACR) criteria for
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SOURCE Novartis Pharmaceuticals Corporation
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