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Jun 22, 2011

FDA Committee Votes Against Green-Lighting Novartis’ Gouty Arthritis sBLA

  • An FDA advisory committee has voted against recommending the sBLA for Novartis’ ACZ885 (canakinumab) in the treatment of gouty arthritis in patients who don’t obtain adequate relief using NSAID drugs or colchicine. Although the advisory committee was happy with the efficacy of the drug, its concerns lay with overall safety. The committee has, as a result, suggested ACZ885 may be more suitable for a narrower population of patients. Novartis says it now aims to work with FDA to identify the right patient population.

    The recommendation, which FDA is not bound by in terms of making a final regulatory decision, was based on the committee’s review of data from two pivotal Phase III studies in over 450 gouty arthritis patients. Reported by Novartis last month, the study results showed that in comparison with steroid therapy,  treatment with ACZ885 led to better pain relief at 72 hours, and a 56% reduction in the risk of new attacks over six months. 28% of patients receiving ACZ885 experienced new attacks over 24 weeks, compared with 49% of patients treated using the injectable steroid triamcinolone acetonide.  

    ACZ885 is a fully human monoclonal antibody designed to selectively inhibit interleukin-1 beta. The drug is already approved under the brand name Ilaris® in over 45 countries, including the EU and U.S., for the treatment of adults and children with cryopyrin-associated periodic syndromes. Approval applications for canakinumab as a treatment for gouty arthritis in patients for whom other treatment are inadequate were submitted in the EU in 2010 and in the U.S., Canada, and Switzerland in the first quarter of 2011. A final FDA decision is expected during Q3 2011.

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