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6-K: European Regulatory Authority Adopts a Positive Opinion for an Update of the Wegovy® Label to Reflect Risk Reduction of Major Adverse Cardiovascular Events

6-K: European Regulatory Authority Adopts a Positive Opinion for an Update of the Wegovy® Label to Reflect Risk Reduction of Major Adverse Cardiovascular Events

6-K：歐洲監管機構對更新Wegovy® 標籤以反映重大心血管不良事件風險降低情況的積極看法
美股SEC公告 ·  07/25 23:48
牛牛AI助理已提取核心訊息
On July 25, 2024, Novo Nordisk A/S announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has endorsed a positive opinion for updating the label of its medication Wegovy (semaglutide 2.4 mg). This update reflects the results from the SELECT cardiovascular outcomes trial, which showed a 20% reduction in major adverse cardiovascular events (MACE) for adults with established cardiovascular disease (CVD) and obesity or overweight without diabetes. The trial, which enrolled 17,604 adults across 41 countries, also indicated reductions in cardiovascular death by 15%, death from any cause by 19%, and an 18% reduction in a heart failure composite endpoint. Despite these findings, the superiority in cardiovascular death and the composite heart failure endpoint were not statistically significant based on the prespecified...Show More
On July 25, 2024, Novo Nordisk A/S announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has endorsed a positive opinion for updating the label of its medication Wegovy (semaglutide 2.4 mg). This update reflects the results from the SELECT cardiovascular outcomes trial, which showed a 20% reduction in major adverse cardiovascular events (MACE) for adults with established cardiovascular disease (CVD) and obesity or overweight without diabetes. The trial, which enrolled 17,604 adults across 41 countries, also indicated reductions in cardiovascular death by 15%, death from any cause by 19%, and an 18% reduction in a heart failure composite endpoint. Despite these findings, the superiority in cardiovascular death and the composite heart failure endpoint were not statistically significant based on the prespecified testing hierarchy. Novo Nordisk expects the label update to be implemented within approximately one month following the CHMP's positive opinion. Wegovy is currently indicated for weight management in adults with obesity or overweight in the EU and the US, with additional indications for reducing the risk of MACE in adults with established CVD in the US.
2024年7月25日，諾和諾德宣佈，歐洲藥品管理局（EMA）人用藥品委員會（CHMP）已支持更新其藥物Wegovy（semaglutide 2.4mg）標籤的積極意見。這一更新反映了SELECt心血管結局試驗的結果，該試驗顯示在已確定存在心血管疾病（CVD）並患有肥胖症或超重但沒有糖尿病的成年人中，重大不良心血管事件（MACE）減少了20%。這項跨越41個國家的試驗納入了17604名成年人，還表明心血管死亡率降低了15%，任何原因導致的死亡率降低了19%，心力衰竭複合終點降低了18%。儘管出現這些發現，但基於預先規定的測試層次結構，心血管死亡率和複合心力衰竭終點的優越性在統計學上並不顯著。諾和諾德預計，在CHMP積極意見後的約一個月內實施標籤更新。Wegovy目前在歐盟和美國的適應症是成人肥胖或超重的體重管理，美國還針對已確定存在CVD的成年人降低MACE的風險進行了額外適應症。
2024年7月25日，諾和諾德宣佈，歐洲藥品管理局（EMA）人用藥品委員會（CHMP）已支持更新其藥物Wegovy（semaglutide 2.4mg）標籤的積極意見。這一更新反映了SELECt心血管結局試驗的結果，該試驗顯示在已確定存在心血管疾病（CVD）並患有肥胖症或超重但沒有糖尿病的成年人中，重大不良心血管事件（MACE）減少了20%。這項跨越41個國家的試驗納入了17604名成年人，還表明心血管死亡率降低了15%，任何原因導致的死亡率降低了19%，心力衰竭複合終點降低了18%。儘管出現這些發現，但基於預先規定的測試層次結構，心血管死亡率和複合心力衰竭終點的優越性在統計學上並不顯著。諾和諾德預計，在CHMP積極意見後的約一個月內實施標籤更新。Wegovy目前在歐盟和美國的適應症是成人肥胖或超重的體重管理，美國還針對已確定存在CVD的成年人降低MACE的風險進行了額外適應症。
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