Investigational Psoriasis Agent On Track for Regulatory Submission This Year


Results from a Phase III trial showed that the experimental drug secukinumab (Novartis) showed superiority to etanercept (Enbrel, Amgen) at clearing skin in patients with moderate-to-severe plaque psoriasis. The FIXTURE trial, which randomized 1,307 patients with moderate-to-severe plaque psoriasis, was designed to demonstrate the efficacy of treatment with subcutaneous secukinumab, compared to placebo and Enbrel, for 12 weeks, while also assessing the safety, tolerability, and long-term efficacy up to 52 weeks. In addition to the study meeting all of its primary and secondary endpoints, the safety profile of secukinumab was found to be consistent with results from Phase II studies in moderate-to-severe plaque psoriasis. Full results from the trial, the first for a drug that selectively targets IL-17A, will be presented at a medical meeting later this year. Novartis also noted that regulatory submissions for secukinumab are on schedule to be filed before the end of 2013.

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