FDA panel endorses efficacy but not safety of Novartis drug ACZ885 for gouty arthritis; did not support approval in proposed indication
An advisory committee of the Food and Drug Administration (FDA) today voted in favor of the overall efficacy but not the overall safety of ACZ885 (canakinumab) to treat gouty arthritis attacks in patients who cannot obtain adequate relief with non-steroidal anti-inflammatory drugs (NSAIDs) or colchicine.
- (1888PressRelease) July 01, 2011 - Committee members raised the potential for use in a more narrow population of gouty arthritis patients.
* Advisory committee strongly endorsed the efficacy of ACZ885 (canakinumab)
* Committee voted against approval of ACZ885 for proposed indication; potential identified for use in more narrow patient population
* Gouty arthritis is a chronic and progressive inflammatory disease of the joints characterized by recurrent attacks of severe pain[1], lasting a week or more[2]
ACZ885, a fully human monoclonal antibody that neutralizes interleukin-1 beta (IL-1 beta)[3], would represent the first new class of therapies in nearly half a century to treat the pain and inflammation of gouty arthritis. Excessive production of IL-1 beta is believed to play a major role in many inflammatory diseases, including gouty arthritis[4].
"We continue to believe in the benefits of ACZ885 for this painful and debilitating disease and will work closely with the FDA to identify the right patient population who will benefit from this therapy," said Trevor Mundel, MD, Global Head of Development at Novartis Pharmaceuticals. "We are encouraged by the committee's enthusiasm and robust discussion and remain committed to addressing the needs of people with gouty arthritis."
The committee's recommendation will be considered by the FDA in its review of the supplemental biologics license application (sBLA) that Novartis submitted for ACZ885. The FDA has the option of seeking the advice of its advisory committees when it is reviewing a new drug approval, although it is not obliged to follow the recommendations.
The recommendation by the committee was based on the results of two pivotal Phase III trials in patients with gouty arthritis. The studies showed patients treated with ACZ885 experienced superior pain relief at 72 hours and a significant reduction in the risk of new attacks over six months, compared to patients treated with the injectable steroid, triamcinolone acetonide (TA)[5].
Gouty arthritis is the most common form of inflammatory arthritis in adults[6]. Chronic and progressive, the disease is characterized by recurrent attacks in the joints[1]. These 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[1],[7]. The intense inflammatory response associated with these attacks may cause severe pain and debilitating symptoms that can last a week or more[1],[2],[7].
About ACZ885 Phase III Studies
The committee reviewed results of two pivotal Phase III studies in which the efficacy of ACZ885 150 mg over 24 weeks was studied in more than 450 gouty arthritis patients. Both trials used an internationally recognized pain scale to measure differences in pain 72 hours after treatment. Patients treated with ACZ885 had a significantly lower mean pain score - a 49.1 millimeter (mm) decrease from baseline - resulting in a statistically significant and clinically meaningful 10.7 mm difference (p
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