Novo Nordisk's GLP-1 Drug Ozempic Receives FDA Label Expansion for Triple Benefits: Glycemic Control, Weight Loss, and Cardiovascular Risk Reduction

January 17, 2020 /BioValleyBIOON/ --DiabetesPharmaceutical giant Novo Nordisk recently announced that the U.S. Food and Drug Administration (FDA) has approved the label expansion of Ozempic (semaglutide, subcutaneous formulation for once-weekly administration) based on a supplemental New Drug Application (sNDA) for type 2 diabetes patients with cardiovascular disease (CVD)DiabetesIn adult patients, reduce the risk of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.

This approval is based on the SUSTAIN 6 cardiovascular outcomes trial (CVOT). The trial demonstrated that in patients with type 2 diabetes at high cardiovascular (CV) risk,DiabetesAmong patients, when combined with standard care, Ozempic statistically significantly reduced the risk of the MACE composite endpoint by 26% compared to placebo.

In addition,FDAThe label for Rybelsus (semaglutide, oral semaglutide tablets, once daily) was also updated to include additional information from the PIONEER 6 cardiovascular outcomes trial (CVOT) demonstrating cardiovascular (CV) safety. This trial was conducted in patients with type 2 diabetes at high cardiovascular risk.DiabetesConducted in patients, the data showed that when combined with standard care, Rybelsus met the primary endpoint of non-inferiority for the composite MACE endpoint compared to placebo, demonstrating CV safety. In the study, the proportion of patients who experienced at least one MACE was 3.8% in the Rybelsus group and 4.8% in the placebo group.

Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer at Novo Nordisk, stated: “We firmly believe in the therapeutic benefits of semaglutide, and this approval marks a significant milestone. Ozempic® now provides an effective treatment option for patients with type 2 diabetes and established cardiovascular disease in the United States, offering both glycemic control and reduced cardiovascular risk. We are also pleased that the results from the PIONEER 6 trial are reflected in the labeling for Rybelsus®. To further evaluate the cardiovascular risk reduction associated with this medication, we are currently conducting the SOUL cardiovascular outcomes trial.”

Semaglutide is a novel long-acting glucagon-like peptide-1 (GLP-1) analog that promotes insulin secretion and inhibits glucagon secretion in a glucose concentration-dependent manner, significantly improving glycemic control in patients with type 2 diabetes while posing a low risk of hypoglycemia. Additionally, semaglutide can induceWeight LossIn addition, semaglutide can significantly reduce the risk of major adverse cardiovascular events (MACE) in patients with type 2 diabetes.

Ozempic (semaglutide, injectable formulation) is a once-weekly subcutaneous injection (0.5 mg or 1 mg) indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. Ozempic was first approved by the U.S. FDA in December 2017 and is currently marketed in 25 countries. First approved in the United StatesFDAApproved for use in combination therapy for adult patients with type 2 diabetes. In the first half of 2019, Ozempic’s sales reached $562 million, with full-year sales projected to surpass the $1 billion mark. Pharmaceutical market research firm EvaluatePharma predicts that Ozempic’s global sales will reach $5.28 billion in 2024, second only toEli Lillyof the GLP-1 agonist Trulicity (expected 2024 sales of $7.13 billion).

Rybelsus (semaglutide, oral tablets) is a once-daily oral tablet containing the absorption-enhancing excipient SNAC. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Rybelsus is the world’s first and only oral GLP-1 receptor agonist, administered once daily, with two therapeutic doses: 7 mg and 14 mg. Rybelsus was first approved in the United States in September 2019FDAApproved, and currently under review by multiple regulatory agencies. Rybelsus has very promising commercial prospects; EvaluatePharma predicts that its sales will reach $3.23 billion in 2024. (Bioon.com)

Original Source:Ozempic approved in the US for CV risk reduction in people with type 2 diabetes and established CVD