Novo Nordisk has recently announced results from a post hoc analyses based on the cardiovascular (CV) outcomes trials SUSTAIN 6 and LEADER, analysing Ozempic (semaglutide) and Victoza (liraglutide) in patients with type II diabetes at high CV risk.
The analysis found that significant beneficial effects on kidney function and renal outcomes were seen with Ozempic and Victoza, with fewer people showing a persistent eGFR reduction and people with pre-existing kidney disease achieving significantly slower annual loss of kidney function versus placebo.
The GLP-1 agonist was found to be non-inferior to placebo in the PIONEER 6 trial, with 3.8% of patients taking it experiencing cardiovascular complications compared to 4.8% of the control group, with an added 50% reduction in death.
Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk told PharmaTimes exclusively that “All these investments; the SOUL trial, the FLOW trial, the STEP trial and FOCUS trial - in a matter of a few weeks we have started three major outcome studies which is a really unique situation for one single medicinal product. It’s because we aim to invest heavily in semaglutide, to show that it has all of these possible indications. So, that’s the dream come true for us and for the patients too I believe.”
He went on to explain why the drugs are important for this area of significant unmet need, saying: “SGLT-2 inhibitors are doing great things for the kidneys. However, that’s for one class of patients only, and they don’t have any anti-diabetic action because they are dependent on the kidneys filtering, and when they kidneys stop filtering, they stop working.
“Even though they can protect the kidneys, they can’t do anything for the diabetic condition when patients have severely impaired renal function. But, Ozempic and Victoza work independently from the kidneys. They are not eliminated by the kidneys and they can even be given to a patient via haemodialysis.
“They can be given to patients with any degree of kidney dysfunction or impairment. So, it is a relatively unique situation. Victoza saw a 22% kidney improvement and Ozempic saw 36%, in the LEADER and SUSTAIN 6 trials respectively.”
Despite reno protective standard of care recommendations, up to 40% of people with type II diabetes develop chronic kidney disease, but Novo Nordisk are aiming for “semaglutide to be the director of the metabolic orchestra”, and for it to be see as “more of a cardio metabolic renal agent, tackling the whole complex.”
Ozempic was approved by the European Commission on 8 February 2018, based on the SUSTAIN programme, a global clinical development programme that comprised eight phase 3a trials, encompassing more than 8,000 adults with type II diabetes.
In Europe, approved in 2009, Victoza is indicated for the treatment of adults with insufficiently controlled type II diabetes together with diet and exercise, as monotherapy when metformin is considered inappropriate due to intolerance or contraindications and in addition to other medicinal products for the treatment of diabetes.