随着 nemolizumab 在 FDA 的批准，期待其在全球范围内的上市能够给更多患者带来希望。Galderma 还正在积极与其他多个国家的监管机构合作，期盼这款重磅药物能更广泛地服务于全球患者。根据统计，目前在美国，约有 181,000 名患者正受到 prurigo nodularis 的困扰，而这款新药的上市，无疑为他们打开了一扇希望之窗。...
The drug is the first approved monoclonal antibody specifically designed to inhibit the IL-31 pathway, a driver of prurigo nodularis. On August 13, an approval by the US Food and Drug Administration (FDA) was announced for nemolizumab (Nemluvio) treatment of adults with prurigo nodularis, a...
“The US FDA’s rapid approval of Nemluvio in prurigo nodularis is a first step in achieving its blockbuster platform potential and reinforces our leadership in therapeutic dermatology,” Flemming Ørnskov, CEO of Galderma, said in the news release.1 Nemolizumab’s approval is based on posit...
“这些结果为 nemolizumab 销售披上了光鲜的外衣,展示了它能够为 prurigo nodularis 患者带来的巨大潜力。”——Baldo Scassellati Sforzolini,Galderma 全球研发负责人 “这一发现显示了 nemolizumab 背后科学的强大与创新,可能成为改善患者生活质量的新希望!”——Sonja Ständer教授,德国明斯特大学医院的皮肤科研...
结节性痒疹(Prurigo nodularis,PN)是一种神经免疫性皮肤病。这种疾病是一种慢性、使人衰弱的皮肤病,伴有潜在的2型炎症,是对生活质量影响最高的炎症性皮肤病之一。患有结节性痒疹的人会经历强烈、持续的瘙痒和全身出现皮肤增厚病变(称为结节),且睡眠质量差。患者通常使用高剂量外用类固醇减轻症状,但若长期使用,则存...
Galderma receives US FDA approval for Nemluvio® (nemolizumab) for adult patients living with prurigo nodularis. News release. August 13, 2024. 注:以上资讯来源于网络,由香港济民药业整理编辑(如有错漏,请帮忙指正),只为提供全球最...
如果Nemolizumab获得批准,将为患者提供一种新的治疗选择。 原始出处: Prurigo Nodularis: Nemolizumab Efficacy Persists at 52 Weeks in Extension Study.https://www.medscape.com/viewarticle/prurigo-nodularis-nemolizumab-efficacy-pers...
“The robust evidence base we have built for nemolizumab in both atopic dermatitis and prurigo nodularis shows the extent of its potential in improving outcomes for these diseases where the burden and unmet needs remain high. We now await the European Commission’s approval decision and hope to...
“The U.S. FDA’s rapid approval of Nemluvio in prurigo nodularis is a first step in achieving its blockbuster platform potential and reinforces our leadership in therapeutic dermatology. We’re confident in the impact this first-in-class therapy will have for patients with prurigo nodularis who...
Galderma Pharma于当地时间8月13日宣布,美国食品药品监督管理局(FDA)已批准Nemluvio(nemolizumab,奈莫利珠单抗)作为预充式皮下注射笔,用于治疗结节性痒疹(PN)成人患者。该产品预计将在未来几周内上市。 结节性痒疹是一种慢性、使人衰弱的神经免疫性皮肤病,伴有潜在的2型炎症。其特征是剧烈瘙痒和覆盖大面积身体的厚...