ChemoCentryx Says FDA Approves Tavneos In ANCA-Associated Vasculitis - Quick Facts

ChemoCentryx称FDA批准Tavneos用于ANCA相关血管炎-快速事实

2021-10-16 09:30:16 RTTNews

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Biopharmaceutical company ChemoCentryx, Inc. announced Friday that the U.S. Food and Drug Administration has approved Tavneos , as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis or ANCA-associated vasculitis or ANCA vasculitis), specifically granulomatosis with polyangiitis and microscopic polyangiitis , in combination with standard therapy. ANCA-associated vasculitis is a systemic autoimmune disease in which over-activation of the complement system further activates neutrophils, leading to inflammation and eventual destruction of small blood vessels. This results in organ damage and failure, with the kidney as the major target, and is often fatal if not treated. Tavneos is the first FDA-approved orally-administered inhibitor of the complement 5a receptor and it will be available to clinicians and patients in the next few weeks. It is also the first-in-a-decade approval of a medicine for ANCA-associated vasculitis. The approval in ANCA-associated vasculitis was supported by the results of the pivotal Phase III ADVOCATE trial. This was a global, randomized, double-blind, active-controlled, double-dummy Phase III trial of 330 patients with ANCA-associated vasculitis in 20 countries. The study met its primary endpoints of disease remission at 26 weeks and sustained remission at 52 weeks, as assessed by the Birmingham Vasculitis Activity Score, or BVAS. The study demonstrated superiority to a prednisone-based standard of care with respect to sustained remission at 52 weeks. ChemoCentryx is responsible for the discovery and development of Tavneos and owns the commercial rights to the drug in the U.S. Vifor Pharma has exclusive rights to commercialize Tavneos in markets outside of the U.S. For comments and feedback contact: editorial@rttnews.com
生物制药公司ChemoCentryx,Inc.周五宣布,美国食品药品监督管理局已批准Tavneos作为严重活动性抗中性粒细胞胞质自身抗体相关脉管炎或ANCA相关脉管炎或ANCA脉管炎成人患者的辅助治疗,特别是肉芽肿病伴多膜炎和显微镜下多膜炎,与标准疗法相结合。 ANCA相关性血管炎是一种全身性自身免疫性疾病,补体系统的过度激活进一步激活中性粒细胞,导致炎症和最终破坏小血管。这导致器官损害和衰竭,肾脏是主要目标,如果不治疗,往往是致命的。 Tavneos是FDA批准的第一个口服补体5A受体抑制剂,它将在未来几周内提供给临床医生和患者。这也是十年来首次批准的治疗ANCA相关血管炎的药物。 ANCA相关性血管炎的批准得到了关键的III期倡导者试验结果的支持。这是一项全球性的、随机的、双盲的、主动对照的、双模拟的III期试验,对象是20个国家的330名ANCA相关性血管炎患者。 根据伯明翰血管炎活动评分(BVAS)的评估,该研究在26周达到了疾病缓解的主要终点,在52周达到了持续缓解。该研究显示,在52周持续缓解方面,优于基于强的松的护理标准。 ChemoCentryx负责Tavneos的发现和开发,并拥有该药物在美国的商业权利。Vifor Pharma拥有Tavneos在美国以外市场商业化的独家权利。 如需评论和反馈,请联系:editorial@rttnews.com

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