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Novartis Cosentyx® meets primary and all secondary endpoints in Phase III trial in patients with polymyalgia rheumatica (PMR)
Globenewswire· 2025-10-22 05:15
Core Insights - Novartis announced that Cosentyx® (secukinumab) achieved significant results in the Phase III REPLENISH trial for treating polymyalgia rheumatica (PMR), meeting both primary and secondary endpoints [1][7] - The trial demonstrated that Cosentyx provided sustained remission compared to placebo at Week 52, indicating its potential as a novel treatment option for PMR [1][7] Company Overview - Novartis is an innovative medicines company focused on improving and extending patients' lives through advanced therapies, reaching nearly 300 million people globally [9] Product Information - Cosentyx is a fully human biologic that inhibits interleukin-17A, a key cytokine in various immune-mediated inflammatory diseases, and is already approved for multiple conditions including psoriatic arthritis and ankylosing spondylitis [4] - Since its launch in 2015, Cosentyx has treated over 1.8 million patients worldwide and is approved in more than 100 countries [4] Clinical Trial Details - The REPLENISH trial was a global Phase III, multicenter, randomized, double-blind, placebo-controlled study conducted in 27 countries, assessing the efficacy and safety of Cosentyx in PMR patients [3] - The primary endpoint was to determine if secukinumab 300mg plus a steroid taper was superior to placebo plus a steroid taper in achieving sustained remission at Week 52 [3] Disease Context - Polymyalgia rheumatica is the second most common inflammatory rheumatic disease in adults aged 50 and older, characterized by significant pain and stiffness, which can severely impact quality of life [5] - Long-term steroid use, the standard treatment, poses risks such as osteoporosis and diabetes, highlighting the need for effective alternatives like Cosentyx [5]