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FDA approves Cosentyx in treating patients with ankylosing spondylitis and psoriatic arthritis in the US

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Additional Relevant Details In the US, it is estimated that up to 0.5% of the population have AS, and up to 1% live with PsA[4],[5]. If not treated effectively, these conditions can lead to irreversible damage to the spine and joints, causing life-long pain and disability that can have a negative impact on even simple tasks in life[2],[3]. There is an urgent unmet need for new medicines for these conditions. Currently many patients are dissatisfied with their treatments, and up to 40% do not respond sufficiently to anti-tumor necrosis factor-alpha (anti-TNFs) therapy[6]. The approvals are based on the efficacy and safety outcomes from four placebo-controlled Phase III studies, which included over 1,500 adult patients with AS or PsA that were biologic treatment naïve or had an inadequate response / were intolerant to anti-TNFs[1]. In the studies, Cosentyx met the primary endpoints achieving statistically significant improvements versus placebo in the signs and symptoms of AS and PsA, as measured by at least a 20% improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS 20*) at Week 16, and a 20% reduction in the American College of Rheumatology (ACR 20) response criteria at Week 24, respectively[1]. ASAS 20 and ACR 20 are standard tools used to assess clinical improvement in AS and PsA. More than 9,600 patients have been treated with Cosentyx in clinical trials across multiple indications, and over 15,000 patients with psoriasis have already been treated in the post-marketing setting[7]. The safety profile of Cosentyx was shown to be consistent with that seen in clinical trials across multiple indications[7],[8-10].
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Jan 15, 2016
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Related Keywords Interleukin-17a, Il-17a, Ankylosing Spondylitis, Psoriatic Arthritis, Fda Approval, Phase Iii Studies, Secukinumab, Anti-tumor Necrosis Factor-alpha Therapy