share_log

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

SEC announcement ·  Mar 5 08:32
Summary by Moomoo AI
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.
Helpful
Not Helpful

This announcement is a separate document:

Doc 1

Disclaimer: This content is for informational and educational purposes only and does not constitute a recommendation or endorsement of any specific investment or investment strategy. Read more