Denmark-based pharmaceutical firm Novo Nordisk has secured the US Food and Drug Administration (FDA) approval of label expansion for Ozempic (semaglutide), based on its supplemental New Drug Application (sNDA).
Ozempic has been indicated for reducing the risk of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack, or non-fatal stroke in adult patients with type 2 diabetes and established cardiovascular disease (CVD).
Novo Nordisk executive vice president and chief science officer Mads Krogsgaard Thomsen said: “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.
“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.”
The US FDA first approved Ozempic in 2017 and is commercialised in 25 countries
Ozempic, an analogue of the naturally occurring hormone glucagon-like peptide-1 (GLP-1), is used in addition to diet and exercise for improving glycaemic control, along with the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.
Novo Nordisk said that the FDA approval is based on the results of SUSTAIN 6 cardiovascular outcomes trial (CVOT), which showed that Ozempic reduced the risk of CV death, non-fatal heart attack or non-fatal stroke by 26%, compared to placebo, when added to standard of care.
SUSTAIN 6 was a randomised, double-blinded, placebo-controlled clinical trial involving in 3,297 adults, to evaluate the CV safety of Ozempic, compared to placebo, when added to standard of care.
In addition to Ozempic, FDA has also approved the label update for Rybelsus, to include additional information from the PIONEER 6 CVOT.
PIONEER 6 CVOT was a randomised, double-blinded, placebo-controlled trial designed to evaluate the CV safety of Rybelsus in 3,183 adults, compared to placebo, when added to standard of care. Rybelsus has reached the primary endpoint of non-inferiority for the composite MACE endpoint in the trial.