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.
週四，歐洲藥品管理局人用藥品委員會對更新諾和諾德A/S（紐約證券交易所代碼：NVO）Ozempic（每週一次的皮下塞馬魯肽）標籤以反映FLOW腎臟療效試驗的數據通過了積極的看法。
The FLOW trial assessed the risk reduction from Ozempic therapy in chronic kidney disease-related events.
FLOW試驗評估了Ozempic療法在慢性腎臟病相關事件中降低的風險。
Also Read: Want To Bet On Ozempic, Wegovy Success? Defiance Introduces Leveraged ETF To Capture Novo Nordisk Momentum
另請閱讀：想押注 Ozempic、Wegovy 的成功嗎？Defiance推出槓桿ETF以捕捉諾和諾德勢頭
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試驗中，semaglutide 1.0 mg顯示出與安慰劑相比，腎臟疾病進展、心血管疾病和腎臟死亡的風險降低了24％，具有統計學意義。
The combined primary endpoint included five components measuring the progression of CKD and the risk of kidney and cardiovascular mortality.
綜合主要終點包括五個組成部分，用於衡量慢性腎臟病的進展以及腎臟和心血管死亡的風險。
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，該試驗的次要終點顯示，重大心血管事件的風險降低了18％，全因死亡的風險降低了20％。
Novo Nordisk has also filed for a label expansion in the US, and a decision is expected in the first half of 2025.
諾和諾德還申請了在美國的品牌擴張，預計將在2025年上半年做出決定。
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.
上週，美國處方儲蓄平台GoodRx Holdings（納斯達克股票代碼：GDRX）發佈了最新的減肥藥物追蹤報告，顯示禮來公司（紐約證券交易所代碼：LLY）的Mounjaro和Zepbound以及諾和諾德的Ozempic和Wegovy等流行減肥藥物的使用量急劇增加。
Despite limited insurance coverage and high out-of-pocket costs, demand for these medications is soaring.
儘管保險範圍有限且自付費用很高，但對這些藥物的需求卻在飆升。
Price Action: NVO stock is down 1.8% at $109.68 at last check Thursday.
價格走勢：週四最後一次檢查時，NVO股價下跌1.8％，至109.68美元。
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