Novo Nordisk Announces FDA Approves a Label Expansion Based on a Supplemental New Drug Application for Ozempic® for the Indication of Reducing the Risk of Major Dverse Cardiovascular Events Including Cardiovascular Death, Non-Fatal Heart Attack, or Non-Fatal Stroke in Adults with Type 2 Diabetes and Established Cardiovascular Disease
January 17, 2020 at 09:23 pm
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Novo Nordisk announced that the US Food and Drug Administration has approved a label expansion based on a supplemental New Drug Application (sNDA) for Ozempic® for the indication of reducing the risk of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack, or non-fatal stroke in adults with type 2 diabetes and established cardiovascular disease (CVD). The approval is based on the SUSTAIN 6 cardiovascular outcomes trial (CVOT), which demonstrated that Ozempic® statistically significantly reduced the risk of CV death, non- fatal heart attack or non-fatal stroke by 26% versus placebo, when added to standard of care in people with type 2 diabetes with increased CV risk. The FDA also updated the Rybelsus® label to include additional information from the PIONEER 6 CVOT demonstrating CV safety. Rybelsus® demonstrated CV safety by meeting the primary endpoint of non-inferiority for the composite MACE endpoint. The proportion of patients who experienced at least one MACE was 3.8% with Rybelsus® and 4.8% with placebo.
Novo Nordisk A/S specializes in the design, manufacture and marketing of pharmaceutical products. Net sales break down by family of products as follows:
- diabetes and obesity treatment products (92.6%);
- rare disease treatment products (7.4%): intended for the treatment of haemophilia, blood disorders, hormonal disorders, etc.
Net sales are distributed geographically as follows: Europe/Middle East/Africa (21.9%), the United States (54.9%), North America (3.9%), China (7.2%) and other (12.1%).
Novo Nordisk Announces FDA Approves a Label Expansion Based on a Supplemental New Drug Application for Ozempic® for the Indication of Reducing the Risk of Major Dverse Cardiovascular Events Including Cardiovascular Death, Non-Fatal Heart Attack, or Non-Fatal Stroke in Adults with Type 2 Diabetes and Established Cardiovascular Disease