Novo Nordisk plans to seek FDA approval for the GLP-1 receptor agonist in the first half of 2019.
Novo Nordisk announced late Friday a 21% reduction in cardiovascular events in topline results for its oral version of semaglutide, a once-a-day tablet version of a glucagon-like peptide-1 receptor agonist already approved as once-weekly injection. The results were largely driven by a 51% reduction in the reduction of cardiovascular death, according to a statement from the company.
The results for the oral version of the type 2 diabetes (T2D) therapy showed it achieved noninferiority for major adverse cardiovascular events (MACE) compared with placebo, in addition to standard of care. The primary end point for MACE in the trial for oral semaglutide, called PIONEER 6, was a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke; the hazard ratio (HR) was 0.79 in favor or oral semaglutide.
Novo Nordisk reported statistically significant reductions in cardiovascular death (HR, 0.47; P = .03) and all-cause mortality (HR, 0.51; P = .008) for oral semaglutide compared with placebo. Results for MI (HR, 1.18) and stroke (HR, 0.74) were more similar between the 2 treatment arms, according to the statement from the company.
In its statement, Novo Nordisk said reductions in glycated hemoglobin, body weight, and blood pressure were similar to those seen in previous trials. The safety profile was similar as well.
"We are very encouraged that PIONEER 6 demonstrated cardiovascular safety as well as a significant reduction in both CV and all-cause mortality following oral semaglutide treatment in people with type 2 diabetes at high cardiovascular risk," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, in a statement.
Novo Nordisk expects to seek regulatory review with FDA and European authorities in the first half of 2019. It received FDA approval in December 2017 for the injectable form of semaglutide, sold as Ozempic. The company has been working since August 2018 on seeking a cardiovascular indication based on the combined results of PIONEER 6 and SUSTAIN 6, the cardiovascular trial used for the injectable form of the therapy.