Amgen Gets FDA Approval for Autoimmune Disorder Treatment

Dow Jones12-12 07:33

By Kelly Cloonan

Amgen received approval from the Food and Drug Administration for its treatment for generalized myasthenia gravis, an autoimmune disorder.

The pharmaceutical company said Thursday the drug Uplizna has the potential for long-term disease control with two doses a year after two initial loading doses.

The approval was based on data from a Phase 3 study of the drug, the company said.

Generalized myasthenia gravis is a rare, chronic autoimmune disorder that impairs neuromuscular communication and can cause fluctuating muscle weakness. It can cause symptoms that compromise daily functions including speaking and seeing, Amgen said.

Uplizna has also been previously approved for two other indications, Amgen said.

Write to Kelly Cloonan at kelly.cloonan@wsj.com

(END) Dow Jones Newswires

December 11, 2025 18:33 ET (23:33 GMT)

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It can cause symptoms that compromise daily functions including speaking and seeing, Amgen said. \n\n\n  Uplizna has also been previously approved for two other indications, Amgen said. \n\n\n \n\n\n  Write to Kelly Cloonan at kelly.cloonan@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  December 11, 2025 18:33 ET (23:33 GMT)\n\n\n  Copyright (c) 2025 Dow Jones & Company, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.35.11","shortVersion":"4.35.11","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2590476265","isCrawlerRequest":true}