<div id="readability-page-1">04:29 AM EST, 12/12/2025 (MT Newswires) -- Amgen ( AMGN ) said late Thursday the US Food and Drug Administration approved Uplizna to treat adults with generalized myasthenia gravis, who test positive for certain related antibodies.The label includes twice-yearly dosing after two starter doses, and it is backed by results from a phase 3 study.Uplizna showed a 1.9-point difference versus placebo on a daily activities symptom score at week 26, and the benefits in antibody-positive patients continued through week 52, Amgen ( AMGN ) said.The most adverse side effects in the trial were headache and infusion-related reactions, according to the company.Generalized myasthenia gravis is a rare autoimmune disorder that causes fluctuating neuromuscular weakness. MT Newswires does not provide investment advice. Unauthorized reproduction is strictly prohibited.</div>

安进

安进宣布，FDA 已批准 Uplizna 用于治疗检测出特定抗体的成人广泛性重症肌无力。该治疗在初始剂量后每年进行两次给药，并得到了三期研究结果的支持。与安慰剂相比，Uplizna 在症状改善方面显示出显著效果，疗效持续时间可达 52 周。常见副作用包括头痛和与输注相关的反应

安进公司表示，美国食品药品监督管理局（FDA）已批准 Uplizna 用于治疗自身免疫性疾病