作者MA40433 (Masa)
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标题[新闻] US FDA accepts Novo Nordisk's applicat
时间Sat May 3 11:44:15 2025
原文标题:
US FDA accepts Novo Nordisk's application for oral Wegovy for weight loss
原文连结:
https://reurl.cc/nmlj26
发布时间:
May 3, 2025
记者署名:
Hollie Adams By Reuters
原文内容:
May 2 (Reuters) - The U.S. Food and Drug Administration has accepted Novo
Nordisk's (NOVOb.CO), opens new tab marketing application for an oral version
of its weight-loss drug Wegovy and will decide in the fourth quarter, the
Danish drugmaker said on Friday.
The company's experimental once-daily version will become the first oral
GLP-1 for chronic weight management, if approved.
U.S.-listed shares of Novo added to session gains and were last up 5.72% at
$69.36 following the news.
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Novo Nordisk's oral GLP-1 drug Rybelsus, which also has the same active
ingredient semaglutide, is already approved for blood sugar control in adults
with diabetes.
Novo, Eli Lilly (LLY.N), opens new tab and several drug developers are racing
to introduce oral weight-loss pills as an easy-to-use treatment in a market
dominated by injections, encouraged by estimates that obesity treatment sales
could hit $150 billion in the coming years.
Last month, Lilly said its experimental pill, orforglipron, helped patients
with type 2 diabetes lose 16 pounds, or nearly 8% of their body weight, over
40 weeks.
The company will report data from another trial for the pill for weight
management later in the year. It plans to file for approval with global
regulators for weight loss by the end of this year and for diabetes next year.
Lilly's injectable tirzepatide is sold under the brand names Mounjaro for
diabetes and Zepbound for weight loss.
Novo's application is based on results from a late-stage trial, which studied
25 milligram dose of oral semaglutide compared to placebo in 307 adults with
obesity with one or more comorbidities.
The company is also studying weight-loss pill amycretin, which targets the
same gut hormone that Wegovy mimics, known as GLP-1, but also a pancreas
hormone called amylin that affects hunger. It is also testing a subcutaneous
version of the drug.
Novo has come under pressure as investors worried about the growing
competition with Lilly as well as disappointing data from its next-generation
weight-loss candidate CagriSema, which the company hopes will be a powerful
successor to Wegovy.
Reporting by Sriparna Roy in Bengaluru; Editing by Sriraj Kalluvila
心得/评论:
FDA同意Novo的新减肥药物Wegovy口服版的药物申请
结果预计在4Q25出炉
如果同意的话将是第一个口服剂新药
受此消息激励 周五NVO上涨5.53%
从川普上任之後所有制药类股均受到明显压缩
这算是难得的激励消息
去年NVO股价约在110以上 但今年4月初跌破60
看看这波会回到甚麽时候
希望能到80以上
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1F:推 goodevening : 跌成屎 有够惨 nvox几个月20变6元 05/03 11:46
2F:推 sova0809 : 礼来会受影响吗 05/03 11:48
3F:推 mystage : 可以捡药厂股票 05/03 11:51
4F:推 mcgrady12336: NVO在跌礼来也搞出口服GLP1了啦 05/03 12:31