European Regulator Backs Approval Of Novo Nordisk High-Dose Wegovy

Benzinga12-13

On Friday, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Novo Nordisk A/S’ (NYSE:NVO) higher dose of Wegovy (semaglutide 7.2...

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The new dose of Wegovy has demonstrated an average weight loss of 20.7% at 72 weeks in people with obesity who do not have diabetes.These substantial weight loss results complement the already established health benefits of Wegovy in obesity-related complications, including a significant reduction in the risk of cardiovascular events such as heart attack and stroke, and a reduction in pain from knee osteoarthritis.In people with obesity and without diabetes, one in three participants treated with Wegovy achieved 25% or more weight loss at 72 weeks, with a safety and tolerability profile consistent with the approved Wegovy 2.4 mg semaglutide dose.Data showed that the majority (84%) of the weight lost with Wegovy came from fat mass loss","collect":0,"end_time":0,"defaultTopTitle":"benzinga.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"IE00BZ1G4Q59.USD":"LEGG MASON CLEARBRIDGE US EQUITY SUSTAINABILITY LEADER \"A\"(USD) INC (A)","BK4532":"文艺复兴科技持仓","BK4599":"减肥药","EMA":"Emera Inc.","IE00BKVL7J92.USD":"Legg Mason ClearBridge - US Equity Sustainability Leaders A Acc USD","BK4081":"电力公用事业","LU0154236417.USD":"BGF US FLEXIBLE EQUITY \"A2\" ACC","NVO":"诺和诺德","BK4007":"制药","LU1093756325.SGD":"FTIF - Franklin K2 Alt Strat Fd A (acc) SGD-H1","CHMP":"冠军工业","BK4588":"碎股","BK4585":"ETF&股票定投概念","LU1093756168.USD":"FRANKLIN K2 ALTERNATIVE STRATEGIES \"A\" (USD) ACC","BK4087":"商业印刷"},"translate_title":"欧洲监管机构支持批准诺和诺德高剂量Wegovy","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"CHMP":1,"EMA":1,"NVO":1.5},"content_text":"On Friday, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Novo Nordisk A/S’ (NYSE:NVO) higher dose of Wegovy (semaglutide 7.2 mg).\nNovo Nordisk has also applied to the EMA for a single-dose device to deliver Wegovy 7.2 mg.\nAdditionally, semaglutide 7.2 mg is currently under review in the U.S., U.K., and several other countries.\nAlso Read: FDA Weighs Rapid Review For Eli Lilly Obesity Pill As Novo Nordisk Nears Launch\nIn the U.S., Novo Nordisk received the Commissioner’s National Priority Voucher (CNPV) and submitted semaglutide 7.2 mg to the FDA in November 2025.\nThe new dose of Wegovy has demonstrated an average weight loss of 20.7% at 72 weeks in people with obesity who do not have diabetes.\nThese substantial weight loss results complement the already established health benefits of Wegovy in obesity-related complications, including a significant reduction in the risk of cardiovascular events such as heart attack and stroke, and a reduction in pain from knee osteoarthritis.\nThe positive opinion is based on the results from the STEP UP and STEP UP T2D clinical program.\nIn people with obesity and without diabetes, one in three participants treated with Wegovy achieved 25% or more weight loss at 72 weeks, with a safety and tolerability profile consistent with the approved Wegovy 2.4 mg semaglutide dose.\nData showed that the majority (84%) of the weight lost with Wegovy came from fat mass loss, with tests confirming that muscle function was preserved.\nNVO Price Action: Novo Nordisk shares were up 0.05% at $50.31 at the time of publication on Friday, according to Benzinga Pro data.\nRead Next:\nPhoto by Tobias Arhelger via Shutterstock","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":1,"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":"4.35.12","shortVersion":"4.35.12","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/2591384686","isCrawlerRequest":true}