The FINANCIAL — Novo Nordisk on October 25 announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) and a Type II Variation application to the European Medicines Agency (EMA) for including data from the LEADER cardiovascular outcomes trial in the product information of Victoza (liraglutide).
In the LEADER trial, Victoza statistically significantly reduced the risk of cardiovascular death, non-fatal myocardial infarction (heart attack) and non-fatal stroke by 13% versus placebo, when added to standard of care. The overall risk reduction was derived from a statistically significant 22% reduction in cardiovascular death with Victoza treatment versus placebo and non-significant reductions in non-fatal myocardial infarction and non-fatal stroke, according to Novo Nordisk.
The safety profile of Victoza in LEADER was generally consistent with previous liraglutide clinical trials.
“Reducing the risk of cardiovascular death in people with type 2 diabetes remains a significant unmet need and it is encouraging that we now have the opportunity to help address this challenge,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “Victoza® is the first GLP-1 receptor agonist to show cardiovascular risk reduction in adults with type 2 diabetes at high cardiovascular risk and we look forward to working with the regulatory authorities as they review the data from the LEADER trial.”
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