Global health care company Novo Nordisk A/S (CPH:NOVOB) announced on Thursday the approval by the US Food and Drug Administration (FDA) of 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).
Reportedly, this 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.
Also, the FDA 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.
Rybelsus was approved by the FDA in September 2019 and is currently under review by several regulatory agencies, including the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.
SUSTAIN 6 was an event and time-driven CVOT for Ozempic. It was a randomised, double-blinded, placebo-controlled trial evaluating the CV safety of Ozempic versus placebo when added to standard of care in 3,297 adults with type 2 diabetes with established CVD or high risk of CV events. PIONEER 6 was a purely event-driven, pre-approval CVOT for oral semaglutide. It was a randomised, double-blinded, placebo-controlled trial evaluating the CV safety of Rybelsus versus placebo when added to standard of care in 3,183 adults with type 2 diabetes with established CVD or high risk of CV events.
In addition, Novo Nordisk is conducting SOUL, a CVOT for Rybelsus in 9,642 people with type 2 diabetes and established cardiovascular disease, investigating the effects of oral semaglutide on the incidence of MACE, compared to placebo, both on top of standard of care.
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