ADA 2016: Data from LEADER will allow Victoza to compete directly with Jardiance in type 2 diabetes patients with high CV risk.
By Rajan Sharma, Senior Analyst
19 June 2016
I joined Datamonitor Healthcare in late in 2013 after completing a Masters in Pharmacology from the University of Oxford...
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Data presented from LEADER, Victoza’s (liraglutide; Novo Nordisk) large-scale cardiovascular outcomes trial (CVOT), on Monday 13 June were undoubtedly the highlight of the American Diabetes Association’s 76th Scientific Sessions (ADA 2016) in New Orleans. The market-leading glucagon-like peptide-1 (GLP-1) agonist demonstrated a statistically significant reduction of 13% in the risk of the composite primary endpoint of cardiovascular (CV) death, non-fatal myocardial infarction (MI), or non-fatal stroke, compared to placebo. Although caution must be exerted when comparing across trials, Victoza’s CVOT data will inevitably provoke comparisons with the results of sodium-glucose cotransporter-2 inhibitor Jardiance’s (empagliflozin; Boehringer Ingelheim/Eli Lilly) dedicated CVOT, which also demonstrated a positive impact on outcomes. Both drugs appear to offer differing CV benefits, adding further complexity to prescribing practices in type 2 diabetes patients at high risk of adverse CV events.
The LEADER trial data provide Victoza with an advantage over other GLP-1 agonists, as previous CVOTs within the class have failed to show a CV benefit. Victoza demonstrated a statistically significant reduction in the risk of CV death and numerical reductions in the risk of non-fatal MI and non-fatal stroke in the 9,430-patient, five-year trial. The drug also showed a statistically significant reduction in the trial’s expanded CV endpoint, which included rates of unstable angina leading to hospitalization, coronary revascularization, and hospitalization for heart failure.
Difference in key cardiovascular outcomes between Victoza and placebo
Comparison of key cardiovascular outcomes between Victoza and Jardiance
The reduction in risk of the three-point MACE primary endpoint shown by Victoza in the LEADER trial was similar to that demonstrated by Jardiance in its CVOT. However, Victoza demonstrated a reduction in the risk of all three components of the composite endpoint, while Jardiance’s benefit was predominantly observed in CV death and hospitalizations due to heart failure in its expanded endpoint. These distinctions provide rationale for potentially differing uses of each therapy in type 2 diabetes.
Datamonitor Healthcare expects the data from the LEADER trial to alter physicians’ prescribing behaviour when treating type 2 diabetes patients who are at particularly high risk of adverse CV outcomes. Jardiance’s startling reduction in hospitalizations due to heart failure means it is likely to remain the preferred option in patients at high risk of, or with pre-existing, heart failure. As Victoza’s beneficial effect was observed across a broader range of CV outcomes, it will likely experience the majority of its use in patients at risk of atherosclerotic events, a view that was suggested by physicians and key opinion leaders at the conference. This strategy is consistent with each company’s planned supplemental New Drug Applications. Novo Nordisk has indicated that it expects to achieve a broader CV indication for Victoza based on LEADER’s primary endpoint compared to Jardiance’s more specific indication for heart failure and CV death, which may influence prescribing trends and payer negotiations (Pink Sheet, 2016). The type 2 diabetes market is expected to be further fragmented upon the launch of Novo Nordisk’s pipeline once-weekly GLP-1 agonist semaglutide. The company has announced that this drug has also demonstrated a positive impact on CV outcomes in type 2 diabetes patients in the SUSTAIN 6 trial (Novo Nordisk, 2016), with full data expected to be presented at the European Association for the Study of Diabetes Annual Meeting in September 2016.
ADA (2016) American Diabetes Association 76th Scientific Sessions. 10–14 June, New Orleans.
Novo Nordisk (2016) Company announcement. Available from: https://www.novonordisk.com/bin/getPDF.2007805.pdf [Accessed 16 June 2016].
Pink Sheet (2016) Novo Will Go After MACZ Indication For Victoza Based on LEADERS. Available from: https://www.pharmamedtechbi.com/publications/the-pink-sheet-daily/2016/6/14/novo-will-go-after-mace-indication-for-victoza-based-on-leader [Accessed 16 June 2016].
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