share_log

Novo-Nordisk A/S | 6-K: Wegovy® Approved in the Us for Cardiovascular Risk Reduction in People with Overweight or Obesity and Established Cardiovascular Disease

諾和諾德 | 6-K:Wegovy®在美國獲批,用於降低超重或肥胖以及已知心血管疾病患者的心血管風險

SEC announcement ·  03/08 14:56
Moomoo AI 已提取核心訊息
On March 8, 2024, Novo Nordisk A/S announced that the US Food and Drug Administration (FDA) has approved a label expansion for its drug Wegovy, allowing it to be used for reducing cardiovascular risks in adults with overweight or obesity who have established cardiovascular disease. This approval was based on the SELECT trial, which showed a 20% reduction in major adverse cardiovascular events (MACE) compared to placebo. The trial also indicated a 15% reduction in cardiovascular death and a 19% reduction in death from any cause, although these findings did not meet all statistical significance thresholds. Novo Nordisk, a global healthcare company headquartered in Denmark, is also seeking label expansion in the EU, with a decision expected in 2024. The company's shares are traded on Nasdaq Copenhagen and the New York Stock Exchange.
On March 8, 2024, Novo Nordisk A/S announced that the US Food and Drug Administration (FDA) has approved a label expansion for its drug Wegovy, allowing it to be used for reducing cardiovascular risks in adults with overweight or obesity who have established cardiovascular disease. This approval was based on the SELECT trial, which showed a 20% reduction in major adverse cardiovascular events (MACE) compared to placebo. The trial also indicated a 15% reduction in cardiovascular death and a 19% reduction in death from any cause, although these findings did not meet all statistical significance thresholds. Novo Nordisk, a global healthcare company headquartered in Denmark, is also seeking label expansion in the EU, with a decision expected in 2024. The company's shares are traded on Nasdaq Copenhagen and the New York Stock Exchange.
2024年3月8日,諾和諾德A/S宣佈,美國食品藥品監督管理局(FDA)已批准擴大其藥物Wegovy的標籤,允許其用於降低已確診心血管疾病的超重或肥胖成年人的心血管風險。該批准基於SELECT試驗,該試驗顯示,與安慰劑相比,主要心血管不良事件(MACE)減少了20%。該試驗還表明,心血管死亡減少了15%,任何原因造成的死亡減少了19%,儘管這些發現並未達到所有統計學顯著性閾值。總部位於丹麥的全球醫療保健公司諾和諾德也在尋求在歐盟擴張品牌,預計將在2024年做出決定。該公司的股票在哥本哈根納斯達克和紐約證券交易所上市。
2024年3月8日,諾和諾德A/S宣佈,美國食品藥品監督管理局(FDA)已批准擴大其藥物Wegovy的標籤,允許其用於降低已確診心血管疾病的超重或肥胖成年人的心血管風險。該批准基於SELECT試驗,該試驗顯示,與安慰劑相比,主要心血管不良事件(MACE)減少了20%。該試驗還表明,心血管死亡減少了15%,任何原因造成的死亡減少了19%,儘管這些發現並未達到所有統計學顯著性閾值。總部位於丹麥的全球醫療保健公司諾和諾德也在尋求在歐盟擴張品牌,預計將在2024年做出決定。該公司的股票在哥本哈根納斯達克和紐約證券交易所上市。
声明:本內容僅用作提供資訊及教育之目的,不構成對任何特定投資或投資策略的推薦或認可。 更多信息