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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
About Ozempic
Ozempic (once-weekly semaglutide) is an analogue of the naturally occurring hormone glucagon-like peptide-1 (GLP-1). It is administered in a once-weekly injection of 0.5 mg or 1 mg and indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes as well as to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease. Ozempic was first approved by the
About Rybelsus
Rybelsus (oral semaglutide) is an analogue of the naturally occurring hormone GLP-1, and it is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes. Rybelsus is the world's first and only GLP-1 in a tablet. It is administered once daily and is approved for use in two therapeutic dosages, 7 mg and 14 mg.
Rybelsus was approved by the
About SUSTAIN 6 and PIONEER 6
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.
About the SOUL trial
Contact:
Tel: +45 3079 3883
Email: mkd@novonordisk.com
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