<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>

安進

安進宣佈，FDA 已批准 Uplizna 用於治療檢測出特定抗體的成人廣泛性重症肌無力。該治療在初始劑量後每年進行兩次給藥，並得到了三期研究結果的支持。與安慰劑相比，Uplizna 在症狀改善方面顯示出顯著效果，療效持續時間可達 52 周。常見副作用包括頭痛和與輸注相關的反應

安進公司表示，美國食品藥品監督管理局（FDA）已批准 Uplizna 用於治療自身免疫性疾病