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]

Core Viewpoint - Novartis is launching a direct-to-patient (DTP) platform in the US on November 1, 2025, allowing cash-paying patients to purchase Cosentyx at a 55% discount off the list price, aiming to improve patient access and affordability [1][6]. Group 1: Product and Pricing Strategy - Cosentyx, Novartis' top-selling product in the US, is a biologic approved for treating multiple immune-mediated inflammatory diseases and has been used by over 1.8 million patients globally since its launch in 2015 [1][4]. - The DTP platform will reflect the average savings that insurers and pharmacy benefit managers receive, serving as a proof-of-concept for a direct-selling model for specialty medicines [2][6]. - Novartis plans to expand the DTP option to additional medicines in its portfolio and is exploring a direct-to-business model to sell Cosentyx to large employers [2][6]. Group 2: Patient Assistance Programs - Novartis offers various programs to assist patients in accessing Cosentyx, including options for eligible patients with commercial insurance to pay as little as $0 for their prescriptions [3]. - The Novartis Patient Assistance Foundation provides Cosentyx at no cost for uninsured patients or those with government insurance who meet specific income guidelines [3]. Group 3: Company Overview - Novartis is committed to innovation in medicine development and delivery, aiming to remove barriers in the healthcare system to better serve patients [2][8]. - The company reaches nearly 300 million people worldwide with its medicines, emphasizing its mission to improve and extend lives [8].