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Novo-Nordisk A/S | 6-K: Novo Nordisk Announced the Headline Results from the Kidney Outcomes Trial FlOW

諾和諾德 | 6-K:諾和諾德公佈腎臟結果試驗FlOW主要結果

SEC announcement ·  03/05 21:32
牛牛AI助理已提取核心訊息
Novo Nordisk A/S announced positive results from its FLOW kidney outcomes trial on March 5, 2024. The trial, which was stopped early due to efficacy on October 10, 2023, demonstrated a 24% reduction in the risk of kidney disease progression and related mortality in patients with type 2 diabetes and chronic kidney disease (CKD) using semaglutide 1.0 mg. The trial met its primary endpoint, showing a statistically significant reduction in the progression of CKD and risk of cardiovascular and kidney death compared to placebo. The trial enrolled 3,533 participants across 28 countries and was conducted at approximately 400 sites. Novo Nordisk plans to seek regulatory approvals for a label expansion for Ozempic in the US and EU in 2024, with detailed trial results to be presented at a scientific conference the same year. Ozempic is currently approved as a treatment to improve glycemic control in adults with type 2 diabetes and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.
Novo Nordisk A/S announced positive results from its FLOW kidney outcomes trial on March 5, 2024. The trial, which was stopped early due to efficacy on October 10, 2023, demonstrated a 24% reduction in the risk of kidney disease progression and related mortality in patients with type 2 diabetes and chronic kidney disease (CKD) using semaglutide 1.0 mg. The trial met its primary endpoint, showing a statistically significant reduction in the progression of CKD and risk of cardiovascular and kidney death compared to placebo. The trial enrolled 3,533 participants across 28 countries and was conducted at approximately 400 sites. Novo Nordisk plans to seek regulatory approvals for a label expansion for Ozempic in the US and EU in 2024, with detailed trial results to be presented at a scientific conference the same year. Ozempic is currently approved as a treatment to improve glycemic control in adults with type 2 diabetes and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.
諾和諾德A/S於2024年3月5日宣佈了其FLOW腎臟預後試驗的陽性結果。該試驗因療效於2023年10月10日提前停止,結果表明,使用索瑪魯肽1.0 mg,2型糖尿病和慢性腎臟病(CKD)患者的腎臟疾病進展風險和相關死亡率降低了24%。該試驗達到了其主要終點,顯示與安慰劑相比,慢性肺病的進展以及心血管和腎臟死亡的風險在統計學上顯著降低。該試驗招募了來自28個國家的3533名參與者,並在大約400個地點進行。諾和諾德計劃在2024年尋求監管部門的批准,以擴大Ozempic在美國和歐盟的標籤,詳細的試驗結果將在同年的科學會議上公佈。Ozempic目前被批准作爲一種治療方法,用於改善2型糖尿病成年人的血糖控制,並降低患有2型糖尿病和已知心血管疾病的成年人發生重大心血管不良事件的風險。
諾和諾德A/S於2024年3月5日宣佈了其FLOW腎臟預後試驗的陽性結果。該試驗因療效於2023年10月10日提前停止,結果表明,使用索瑪魯肽1.0 mg,2型糖尿病和慢性腎臟病(CKD)患者的腎臟疾病進展風險和相關死亡率降低了24%。該試驗達到了其主要終點,顯示與安慰劑相比,慢性肺病的進展以及心血管和腎臟死亡的風險在統計學上顯著降低。該試驗招募了來自28個國家的3533名參與者,並在大約400個地點進行。諾和諾德計劃在2024年尋求監管部門的批准,以擴大Ozempic在美國和歐盟的標籤,詳細的試驗結果將在同年的科學會議上公佈。Ozempic目前被批准作爲一種治療方法,用於改善2型糖尿病成年人的血糖控制,並降低患有2型糖尿病和已知心血管疾病的成年人發生重大心血管不良事件的風險。

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