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醫藥產品委員會對諾和諾德A/S（紐約證券交易所：NVO）的Ozempic（每週注射一次的塞馬戈魯肽）標籤更新採納了積極意見，以反映FLOW腎臟結果試驗的數據。
The FLOW trial assessed the risk reduction from Ozempic therapy in chronic kidney disease-related events.
FLOW試驗評估了Ozempic治療在慢性腎病相關事件中的風險降低。
Also Read: Want To Bet On Ozempic, Wegovy Success? Defiance Introduces Leveraged ETF To Capture Novo Nordisk Momentum
另請閱讀：想要押注於Ozempic和Wegovy的成功嗎？Defiance推出了槓桿可交易ETF以捕捉諾和諾德的動力。
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試驗中，1.0毫克的塞馬戈魯肽相比安慰劑表現出統計學上顯著且優越的24%腎病進展、心血管疾病和腎臟死亡風險降低。
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元件，衡量CKD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，試驗中的次要終點顯示，心血管重大事件的風險降低了18%，而全因死亡風險降低了20%。
Novo Nordisk has also filed for a label expansion in the US, and a decision is expected in the first half of 2025.
諾和諾德還在美國申請了標籤擴展，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，GoodRx Holdings（納斯達克：GDRX）發佈了最新的減肥藥物追蹤器，顯示諾和諾德的Ozempic和Wegovy以及禮來的（紐約證券交易所：LLY）Mounjaro和Zepbound等受歡迎的減肥藥物使用量急劇增加。
Despite limited insurance coverage and high out-of-pocket costs, demand for these medications is soaring.
儘管保險覆蓋有限且自付費用高昂，但對這些藥物的需求正在飆升。
Price Action: NVO stock is down 1.8% at $109.68 at last check Thursday.
價格動向：NVO股票在週四最後一次檢查時下跌了1.8%，報109.68美元。
- Gambling.com Rolls The Dice On OddsJam's Parent; $80M Upfront Consideration For Instant Revenue Boost
- Gambling.com對OddsJam的母公司進行投資；8000萬美元的前期投資可實現即時營業收入提升
譯文內容由第三人軟體翻譯。