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Eli Lilly's Zepbound Receives FDA Approval For Obesity-Linked Sleep Apnea Drug

Eli Lilly's Zepbound Receives FDA Approval For Obesity-Linked Sleep Apnea Drug

礼来公司的Zepbound获得FDA批准用于治疗与肥胖相关的睡眠呼吸暂停药物
Benzinga ·  2024/12/21 22:48

On Friday, the U.S. Food and Drug Administration approved Eli Lilly and Co.'s (NYSE:LLY) weight loss drug Zepbound for treating sleep apnea

周五,美国食品药品监督管理局批准了礼来(NYSE:LLY)公司的减肥药Zepbound用于治疗睡眠 apnea。

What Happened: The FDA's decision makes Zepbound the first approved drug treatment for patients with obesity and moderate-to-severe obstructive sleep apnea, or OSA.

发生了什么:FDA的决定使Zepbound成为第一个获得批准的用于肥胖及中度至重度阻塞性睡眠 apnea(OSA)患者的药物治疗。

"Too often, OSA is brushed off as 'just snoring,'" said Julie Flygare, CEO of Project Sleep, in Eli Lilly's press release. The condition affects an estimated 80 million Americans, with 20 million experiencing moderate-to-severe forms.

“阻塞性睡眠 apnea常常被忽视为‘仅仅是打鼾’,”项目睡眠的首席执行官Julie Flygare在礼来的新闻稿中表示。该控件影响大约8000万美国人,其中2000万人经历中度至重度的症状。

Weight Loss Drug Wars Heat Up: Amgen Challenges Eli Lilly, Novo's Dominance

减肥药物战争白热化:安进对艾 Eli Lilly 和诺和诺德的主导地位发起挑战

In a separate release, the FDA underscored that Zepbound should be used in conjunction with a reduced-calorie diet and increased physical activity for optimal results.

在另一份声明中,FDA强调Zepbound应与低热量饮食和增加的身体活动结合使用以获得最佳效果。

The approval could significantly impact insurance coverage for Zepbound, potentially including Medicare, which currently restricts coverage for obesity drugs unless approved for additional health benefits, noted CNBC.

此批准可能会对Zepbound的保险覆盖产生重大影响,潜在地包括医疗保险,而目前医疗保险对肥胖药物的覆盖有限,除非获得额外健康利益的批准,CNBC指出。

This development also gives Eli Lilly an edge over competitor Novo Nordisk (NYSE:NVO), whose Wegovy isn't approved for sleep apnea treatment.

这一进展还使得礼来在竞争对手诺和诺德(NYSE:NVO)面前占据优势,后者的Wegovy尚未获得睡眠 apnea治疗的批准。

Why It Matters: Zepbound's effectiveness was demonstrated in clinical trials. Results showed that nearly half of patients treated with the highest dose experienced disease resolution, the report noted.

为什么这很重要:Zepbound的有效性在临床试验中得到了证明。结果显示,接受最高剂量治疗的患者中有近一半经历了疾病的缓解,报告指出。

This was defined by a significant reduction in their apnea-hypopnea index (AHI), a key metric in diagnosing OSA.

这通过他们的呼吸暂停-低通气指数(AHI)的显著降低来定义,这是诊断阻塞性睡眠呼吸暂停的重要指标。

The approval also comes as Eli Lilly continues to expand its manufacturing capabilities, including a $3 billion investment in Kenosha County, Wisconsin in December, to meet the growing demand for its diabetes and obesity medicines.

此批准也恰逢礼来继续扩大其制造业-半导体能力,包括在12月份对威斯康星州肯诺沙县的30亿元投资,以满足对其糖尿病和肥胖药物的日益增长的需求。

In October, Eli Lilly reported third-quarter revenue of $11.44 billion, a 20% increase year-over-year, but missed expectations of $12.10 billion. Zepbound generated $1.26 billion.

在10月份,礼来报告第三季度营业收入为114.4亿元,同比增长20%,但未达到121亿元的预期。Zepbound产生了12.6亿元。

Price Action: As per Benzinga Pro, LLY shares increased by 1.35% to $767.76 on Friday. So far this year, LLY has risen by 29.65%.

价格动态:根据Benzinga Pro,LLY股价周五上涨了1.35%,至767.76美元。截至目前,今年LLY股价上涨了29.65%。

The latest ratings from B of A Securities, Wolfe Research, and Deutsche Bank set an average price target of $1,004, indicating a potential upside of 30.77%.

美银证券、沃尔弗研究和德意志银行的最新评级设定了1004美元的平均价格目标,表示潜在上涨幅度为30.77%。

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Disclaimer: This content was partially produced with the help of Benzinga Neuro and was reviewed and published by Benzinga editors.

免责声明:此内容部分由Benzinga Neuro生成,并由Benzinga编辑审核和发布。

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