Novo Nordisk’s semaglutide meets primary endpoint of reducing cardiovascular events at Phase 3

pharmafile | November 26, 2018 | News story | Research and Development, Sales and Marketing Novo Nordisk, diabetes, pharma, semaglutide 

Novo Nordisk has revealed new Phase 3a data for its investigational GLP-1 analogue therapy semaglutide, showing that the drug met its primary endpoint of non-inferiority of major adverse cardiovascular events (MACE) versus placebo in type 2 diabetes patients at high risk of cardiovascular events.

In the study of 3,183 participants, oral semglutide reduced the incidence of MACE by 21%, and reduced occurrence of cardiovascular death by 51%, but the former did not reach statistical significance and the latter. In th elater, it ws noted that there were no significant differences in rates of non-fatal myocardial infarction or non-fatal stroke, but a 49% reduction in all-cause mortality was seen.

The drug also produced similar results to previous studies in terms of improvements to HbA1c levels, body weight and blood pressure.

PIONEER 6 was the final study in the PIONEER programme, which investigated 8,845 patients with type 2 diabetes across ten trials.

“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,” remarked Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer of Novo Nordisk. “Based on the strong clinical data reported throughout the PIONEER clinical trial programme, we have now established a solid efficacy and safety profile for oral semaglutide and we are looking forward to sharing the results with regulatory authorities during 2019.”

Novo Nordisk now plans to file the drug for regulatory approval in the US and EU in the first half of next year.

Matt Fellows

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