Novo Nordisk's Ozempic Label Expansion Snags Approval From European Drug Regulator's Advisory Panel
Novo Nordisk's Ozempic Label Expansion Snags Approval From European Drug Regulator's Advisory Panel
In the FLOW trial, semaglutide 1.0 mg demonstrated a statistically significant and superior 24% risk reduction in kidney disease progression, cardiovascular disease, and kidney death compared to placebo.On Thursday, the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for an update for Novo Nordisk A/S' (NYSE:NVO) Ozempic (once-weekly subcutaneous semaglutide) label to reflect data from the FLOW kidney outcomes trial.
周四，欧洲药品管理局人用医药产品委员会对诺和诺德A/S（纽约证券交易所：NVO）的Ozempic（每周注射一次的塞马戈鲁肽）标签更新采纳了积极意见，以反映FLOW肾脏结果试验的数据。
The FLOW trial assessed the risk reduction from Ozempic therapy in chronic kidney disease-related events.
FLOW试验评估了Ozempic治疗在慢性肾病相关事件中的风险降低。
Also Read: Want To Bet On Ozempic, Wegovy Success? Defiance Introduces Leveraged ETF To Capture Novo Nordisk Momentum
另请阅读：想要押注于Ozempic和Wegovy的成功吗？Defiance推出了杠杆可交易ETF以捕捉诺和诺德的动力。
In the FLOW trial, semaglutide 1.0 mg demonstrated a statistically significant and superior 24% risk reduction in kidney disease progression, cardiovascular disease, and kidney death compared to placebo.
在FLOW试验中，1.0毫克的塞马戈鲁肽相比安慰剂表现出统计学上显著且优越的24%肾病进展、心血管疾病和肾脏死亡风险降低。
The combined primary endpoint included five components measuring the progression of CKD and the risk of kidney and cardiovascular mortality.
综合主要终点包括五个元件，衡量CKD的进展以及肾脏和心血管死亡的风险。
In addition, the secondary endpoints in the trial showed that the risk of major cardiovascular events was reduced by 18%, and the risk of all-cause mortality was reduced by 20%.
此外，试验中的次要终点显示，心血管重大事件的风险降低了18%，而全因死亡风险降低了20%。
Novo Nordisk has also filed for a label expansion in the US, and a decision is expected in the first half of 2025.
诺和诺德还在美国申请了标签扩展，预计将在2025年上半年做出决定。
Last week, GoodRx Holdings (NASDAQ:GDRX), a prescription savings platform in the U.S., released its latest Weight Loss Medications Tracker, revealing a sharp increase in the use of popular weight loss drugs like Eli Lilly And Co's (NYSE:LLY) Mounjaro and Zepbound as well as Novo Nordisk's Ozempic and Wegovy.
上周，GoodRx Holdings（纳斯达克：GDRX）发布了最新的减肥药物追踪器，显示诺和诺德的Ozempic和Wegovy以及礼来的（纽约证券交易所：LLY）Mounjaro和Zepbound等受欢迎的减肥药物使用量急剧增加。
Despite limited insurance coverage and high out-of-pocket costs, demand for these medications is soaring.
尽管保险覆盖有限且自付费用高昂，但对这些药物的需求正在飙升。
Price Action: NVO stock is down 1.8% at $109.68 at last check Thursday.
价格动向：NVO股票在周四最后一次检查时下跌了1.8%，报109.68美元。
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