- Novo Nordisk announced positive data for its once-weekly glucagon-like peptide (GLP)-1 semaglutide at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Germany Friday morning.
- Results from the SUSTAIN 6 trial showed semaglutide significantly reduced the risk of a cardiovascular event, as measured by time to first occurrence of major adverse cardiovascular events (MACE) like a heart attack, non-fatal stroke or cardiovascular death.
- Semaglutide reduced the likelihood of these risk factors by 26% compared with placebo when added to the standard-of-care in patients with type 2 diabetes who were at high cardiovascular risk.
With the results, Novo Nordisk adds to an arsenal of data which could help it better compete in the very crowded diabetes market as it tries to retain its leadership position.
The Danish drugmaker has been fending off competitors to its once-daily GLP-1 Victoza (liraglutide), but unfavorable pricing dynamics (the drug has been left off national formulary lists for the past few years) and new once-weekly dosing entrants to the market have put pressure on the drug.
Semaglutide is Novo Nordisk's follow up to Victoza. The drug is set up to compete with Eli Lilly & Co's Trulicity (dulaglutide), which is already making waves in the market — sales hit $345 million during the first half of 2016.
During the study, there was a significant 39% decrease in non-fatal stroke and a non-significant 26% decrease in non-fatal myocardial infarction in the 3,297-patient study. Yet, there was a higher incidence of diabetic retinopathy in patients taking semaglutide than placebo.
Victoza already showed positive cardiovascular benefits in the 9,000-patient LEADER study and the preliminary data from semaglutide is a good indicator that the drug could perform even better in a large cardiovascular outcomes study.
"The SUSTAIN 6 results further strengthen the clinical evidence for the Novo Nordisk GLP-1 receptor agonist portfolio with the finding of additional benefits beyond glycaemic control and weight loss in adults with type 2 diabetes at high cardiovascular risk," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
The Danish drugmaker intends to submit semaglutide for approval from the U.S. Food and Drug Administration later this year.