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6-K: Oral Semaglutide Demonstrates a 14% Reduction in Risk of Major Adverse Cardiovascular Events in Adults with Type 2 Diabetes in the SOUL Trial

6-K: Oral Semaglutide Demonstrates a 14% Reduction in Risk of Major Adverse Cardiovascular Events in Adults with Type 2 Diabetes in the SOUL Trial

6-K：在SOUL試驗中，口服西瑪魯肽顯示2型糖尿病成年人發生重大心血管不良事件的風險降低了14％
美股SEC公告 ·  10/21 08:34

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Novo Nordisk A/S, a leading global healthcare company, announced on October 21, 2024, the successful results of the SOUL cardiovascular outcomes trial. The trial, which enrolled 9,650 participants with type 2 diabetes and established cardiovascular disease (CVD) and/or chronic kidney disease (CKD), demonstrated a 14% reduction in the risk of major adverse cardiovascular events (MACE) for those treated with oral semaglutide compared to placebo. This primary endpoint included cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. The trial's findings, which also confirmed the safety and tolerability of oral semaglutide, are expected to support regulatory approval for a label expansion of Rybelsus® in the US and EU. Detailed results from the SOUL trial will be presented at a scientific conference in 2025. Novo Nordisk plans to file for the label expansion around the turn of the year.
Novo Nordisk A/S, a leading global healthcare company, announced on October 21, 2024, the successful results of the SOUL cardiovascular outcomes trial. The trial, which enrolled 9,650 participants with type 2 diabetes and established cardiovascular disease (CVD) and/or chronic kidney disease (CKD), demonstrated a 14% reduction in the risk of major adverse cardiovascular events (MACE) for those treated with oral semaglutide compared to placebo. This primary endpoint included cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. The trial's findings, which also confirmed the safety and tolerability of oral semaglutide, are expected to support regulatory approval for a label expansion of Rybelsus® in the US and EU. Detailed results from the SOUL trial will be presented at a scientific conference in 2025. Novo Nordisk plans to file for the label expansion around the turn of the year.
全球領先的健康保健公司諾和諾德（Novo Nordisk A/S）於2024年10月21日宣佈，SOUL心血管結局試驗取得成功的結果。該試驗共招募了9,650名患有2型糖尿病並伴有心血管疾病（CVD）和/或慢性腎病（CKD）的參與者，結果顯示口服塞馬谷胱甘肽治療組的主要不良心血管事件（MACE）風險降低了14%，與安慰劑組相比。這一主要終點包括心血管死亡、非致命性心肌梗死或非致命性中風。該試驗結果還確認了口服塞馬谷胱甘肽的安全性和耐受性，預計將支持Rybelsus®在美國和歐盟擴展使用許可的監管批准。SOUL試驗的詳細結果將於2025年在一場科學會議上進行介紹。諾和諾德計劃在年底前申請標籤擴展。
全球領先的健康保健公司諾和諾德（Novo Nordisk A/S）於2024年10月21日宣佈，SOUL心血管結局試驗取得成功的結果。該試驗共招募了9,650名患有2型糖尿病並伴有心血管疾病（CVD）和/或慢性腎病（CKD）的參與者，結果顯示口服塞馬谷胱甘肽治療組的主要不良心血管事件（MACE）風險降低了14%，與安慰劑組相比。這一主要終點包括心血管死亡、非致命性心肌梗死或非致命性中風。該試驗結果還確認了口服塞馬谷胱甘肽的安全性和耐受性，預計將支持Rybelsus®在美國和歐盟擴展使用許可的監管批准。SOUL試驗的詳細結果將於2025年在一場科學會議上進行介紹。諾和諾德計劃在年底前申請標籤擴展。
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