Novo Nordisk has announced that the US Food and Drug Administration (FDA) has approved a label expansion based on a supplemental New Drug Application (sNDA) for Ozempic (once-weekly semaglutide) 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).
SUSTAIN 6 and PIONEER 6 CVOT
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.
“We strongly believe in the benefits of semaglutide and this approval marks an important milestone. Ozempic now offers people in the US with type 2 diabetes and established cardiovascular disease an effective treatment option to both lower their blood glucose and reduce their cardiovascular risk,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “We also appreciate that the results from the PIONEER 6 study are reflected in the label for Rybelsus and to further evaluate the cardiovascular risk reduction profile we are currently conducting the cardiovascular outcomes trial, SOUL.”
Photo of Mads Krogsgaard Thomsen: Novo Nordisk