Novo Nordisk (NYSE:NVO) has announced that its weight-loss drug liraglutide is safe and effective for children as young as six. The company-funded study revealed a 7.4% reduction in body-mass index for children aged 6 to 12 using the injectable pens over a year compared to a placebo group.
What Happened: The study, involving 82 children, indicates liraglutide could become the first obesity treatment available for this age group. Martin Holst Lange, Novo Nordisk's head of development, stated the company will seek regulatory approval from the U.S. Food and Drug Administration and the European Medicines Agency, reported the Financial Times.
"One in five children have obesity and one of the biggest predictors for adult obesity is childhood obesity so having this potential intervention for that age group is important," Lange said, according to the report.
Currently, no pharmaceutical treatments for general obesity in under-12s exist, according to Claudia Fox from the University of Minnesota Medical School, who led the study. Novo Nordisk is also testing semaglutide, the active ingredient in Ozempic and Wegovy, for young children, which is already approved for over-12s.
Despite promising results, side effects such as nausea and vomiting were noted, and weight was quickly regained after stopping the drug. However, there were no differences in growth, bone age, or puberty issues between the control group and those on liraglutide, Fox added.
Why It Matters: The announcement from Novo Nordisk comes at a time when the weight-loss drug market is under intense scrutiny. Recently, there have been concerns about the distribution of fake versions of weight-loss drugs like Ozempic. Criminals have been forging drug batch numbers to produce counterfeit versions, raising international concerns.
Moreover, research has revealed that semaglutide, the active ingredient in Ozempic, might have unexpected benefits beyond weight loss. According to researchers, the drug could potentially address a range of ailments, including heart failure, arthritis, Alzheimer's, and even cancer.
In addition, the market for weight-loss drugs is rapidly expanding, with companies like Hims & Hers Health Inc. (NYSE:HIMS) offering affordable alternatives to popular medications due to high demand and occasional shortages. However, the sustainability of these alternatives is under question as pharmaceutical giants ramp up production to meet demand.
Furthermore, Eli Lilly (NYSE:LLY) has launched discounted versions of its appetite-suppressing drugs, Mounjaro and Zepbound, to combat imitation versions and address regulatory debates over drug shortages.
Price Action: Novo Nordisk closed at $129.78 on Tuesday, down 1.61% for the day. In after-hours trading, the stock saw a slight uptick, rising 0.54%. Year to date, the stock has gained 27.10%, according to data from Benzinga Pro.
This story was generated using Benzinga Neuro and edited by Kaustubh Bagalkote
諾和諾德(紐約證券交易所代碼:NVO)宣佈,其減肥藥物利拉魯肽對六歲以下的兒童是安全有效的。這項由公司資助的研究顯示,與安慰劑組相比,使用注射筆的6至12歲兒童的體重指數在一年內下降了7.4%。
發生了什麼:這項涉及82名兒童的研究表明,利拉魯肽可能成爲該年齡組可用的第一種肥胖症治療方法。據《金融時報》報道,諾和諾德開發主管馬丁·霍爾斯特·蘭格表示,該公司將尋求美國食品藥品監督管理局和歐洲藥品管理局的監管批准。
報告稱:「五分之一的兒童患有肥胖症,成人肥胖的最大預測指標之一是兒童肥胖,因此對該年齡組進行這種潛在的干預措施很重要。」
領導這項研究的明尼蘇達大學醫學院的克勞迪婭·福克斯表示,目前尚不存在針對12歲以下兒童一般肥胖症的藥物治療方法。諾和諾德還在爲幼兒測試Ozempic和Wegovy中的活性成分索瑪魯肽,該成分已獲准用於12歲以上的兒童。
儘管結果令人鼓舞,但還是出現了噁心和嘔吐等副作用,停藥後體重迅速恢復。但是,福克斯補充說,對照組和服用利拉魯肽的對照組在生長、骨齡或青春期問題上沒有區別。
爲何重要:諾和諾德的這一宣佈是在減肥藥市場受到嚴格審查之際發佈的。最近,有人擔心像Ozempic這樣的假冒減肥藥物的分發。犯罪分子一直在僞造藥品批號來生產假冒藥物,這引起了國際關注。
此外,研究表明,Ozempic中的活性成分索瑪魯肽除了減肥之外還可能有意想不到的好處。根據研究人員的說法,該藥物有可能治療一系列疾病,包括心力衰竭、關節炎、阿爾茨海默氏症,甚至癌症。
此外,減肥藥物市場正在迅速擴大,由於需求旺盛和偶爾出現短缺,Hims & Hers Health Inc.(紐約證券交易所代碼:HIMS)等公司爲流行藥物提供了負擔得起的替代品。但是,隨着製藥巨頭提高產量以滿足需求,這些替代品的可持續性受到質疑。
此外,禮來(紐約證券交易所代碼:LLY)推出了其抑制食慾的藥物Mounjaro和Zepbound的折扣版,以打擊仿製藥並解決有關藥品短缺的監管爭論。
價格走勢:諾和諾德週二收於129.78美元,當天下跌1.61%。在盤後交易中,該股小幅上漲,上漲0.54%。根據Benzinga Pro的數據,今年迄今爲止,該股已上漲27.10%。
這個故事是使用 Benzinga Neuro 創作的,由 Kaustubh Bagalkote 編輯