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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

SEC announcement ·  Mar 8 14:56
Summary by Moomoo AI
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.
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