FDA Approves New Indication For Somaglutide To Reduce Cardiovascular Risk In Diabetic Patients

- Jan 21, 2020-

A few days ago, Novo Nordisk announced that the US FDA has approved the new indication of 0.5 mg or 1 mg of Ozempic (semaglutide, Somalutide) injection for reducing the main symptoms of adult patients with type 2 diabetes and known heart disease. Risk of adverse cardiovascular events (MACE), such as a heart attack, stroke, or death. Additional details about the primary endpoint analysis of PIONEER 6 were added to Rybelsus (oral semaglutide) 7 mg or 14 mg tablets.

Somaglutide is a glucagon-like peptide-1 (GLP-1) analog. It is a hormone that induces insulin secretion and is marketed as Ozempic. The once-weekly injection form was approved by the FDA in 2017 for the treatment of type 2 diabetes. To improve compliance and better long-term results, Novo Nordisk has developed Rybelsus, an oral dosage form of somaglutide, which was approved by the FDA in September 2019.

Cardiovascular disease (CVD) is the leading cause of death and disability in patients with type 2 diabetes. Adults with type 2 diabetes are 2 to 4 times more likely to develop CVD than adults without diabetes.


FDA approval for Ozempic is based on the results of the SUSTAIN 6 Cardiovascular Outcome Trial (CVOT), which assesses the cardiovascular safety of adding Ozempic or placebo to standard treatment for adults with type 2 diabetes and diagnosed cardiovascular disease. In the 2-year SUSTAIN 6 trial, Ozempic significantly reduced the risk of cardiovascular death, non-fatal heart attack, or non-fatal stroke three-component MACE endpoint. Compared to placebo, the estimated MACE relative risk reduction was 26% (HR 0.74 [95% CI: 0.58, 0.95], non-inferiority, median observation time 2.1 years, p <0.001), and the main composite outcome occurred at 6.6% of Ozempic-treated patients and 8.9% of placebo-treated patients. During the trial, the incidence of gastrointestinal adverse events in the Ozempic group was higher than in the placebo group. Most gastrointestinal adverse events occurred during the first 30 weeks.

Novo Nordisk also announced that it has updated section 14 (clinical studies) of Rybelsus prescription information to include analysis of the primary endpoint of the PIONEER 6 CVOT trial, showing the hazard ratio to the first three-component MACE time (HR 0.79 [95% CI : 0.57, 1.11]).

In June 2019, Novo Nordisk initiated a SOUL CVOT trial of 9,642 adults with type 2 diabetes identified to have cardiovascular disease to further evaluate the cardiovascular effects of Rybelsus. The trial is investigating the effect of Rybelsus on the incidence of MACE compared to placebo in addition to standard treatments.