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news.Novartis Pharmaceuticals has released two pivotal Phase III trials results of ACZ885 (canakinumab) which demonstrated superior pain relief and reduced the risk of suffering new attacks by up to 68%, compared to an injectable steroid, in patients with severe gouty arthritis.
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ACZ885 is an investigational fully human monoclonal antibody that inhibits interleukin-1 beta (IL-1 beta), which is part of the body’s immune system defenses.
ACZ885 works by neutralizing IL-1 beta for a sustained period of time, therefore inhibiting inflammation.
The two studies were Phase III, 12-week, randomized, multicenter, double-blind, double dummy, active-controlled studies.
Pain in the affected joint was measured according to an internationally recognized pain scale, the Visual Analog Scale (VAS).
Both studies had the same two primary endpoints: pain intensity at 72 hours post-dose; and time to the first new gouty arthritis attack.
Novartis Pharmaceuticals Division head David Epstein said they are committed to meet this unmet medical need and to further investigate the potential of ACZ885 in a number of other conditions where interleukin-1 beta plays a role.