Novo's next-gen diabetes drug could be best at cutting heart attacks

Novo Nordisk’s semaglutide reduced major cardiovascular events by 26% in high-risk adults with type 2 diabetes, according to new data.

Diabetes patients are particularly at risk of major cardiovascular problems, and companies are now developing treatments which not only control blood glucose, but also reduce the chances of them suffering potentially fatal heart attacks and strokes.

A year ago Eli Lilly and Boehringer Ingelheim produced results which showed their oral SGLT2 inhibitor drug Jardiance (empagliflozin) reduced cardiovascular events by 14% - the first time this had ever been achieved by a diabetes drug, and a potential 'game changer' for patients and clinicians.

Investors had been hoping that Novo could top this with its LEADER trial of GLP-1 drug Victoza, but this achieved a slightly lower 13 % cut in the composite endpoint of CV deaths and non-fatal MI or non-fatal stroke.

Now the new, small scale study of next-generation GLP-1 semaglutide suggests it could be the best yet in cutting the risk, its 26% cut putting it ahead of Victoza and Jardiance.

The new SUSTAIN 6 phase 3 trial data released at the EASD diabetes congress in Munich backs up earlier top line data, and puts the drug in the rare position of having strong outcomes data before approval.

Investors were disappointed with Victoza’s CV data earlier this year – but were clearly more upbeat about the results from semaglutide in the SUSTAIN trial.

Novo Nordisk’s shares ticked up on the Copenhagen stock exchange to 310 Danish Kroner (£35.41) following the news.

The drug is set for filing before the end of 2016, and if approved, semaglutide is predicted to be an important drug for Novo Nordisk. Analysts predict annual sales of more than $2 billion by 2022.

Results showed semaglutide significantly reduced risk of the primary composite endpoint of time to first occurrence of either cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke by 26% versus placebo, when added to standard of care in 3,297 adults with type 2 disease with high CV risk.

These results were based on an accumulation of first major adverse CV events in 254 people.

There was a significant 39% decrease in non-fatal stroke and a non-significant 26% decrease in non-fatal myocardial infarction, and a neutral outcome (2% decrease) in CV death after two years of treatment.

SUSTAIN 6 investigator Dr Steven Marso said the reduction in cardiovascular events is “notable given the small study population and the short trial duration.”

“These findings are clinically relevant, as cardiovascular disease is the leading cause of death in people with type 2 diabetes and new treatment options that can also reduce the risk of cardiovascular events are needed.”

In this outcomes trial, from an overall mean baseline of 8.7%, semaglutide 0.5 mg and 1.0 mg significantly reduced HbA1c by -1.1% and -1.4% vs -0.4% for both placebo 0.5 mg and 1.0 mg at 104 weeks, when added to standard of care.

From a mean baseline of 92.1 kg, adults treated with semaglutide 0.5 mg and 1.0 mg experienced superior and sustained weight loss of -3.6 kg and -4.9 kg, vs -0.7 kg for placebo 0.5 mg and -0.5 kg for placebo 1.0 mg.

The main results from SUSTAIN 6 were presented at the annual meeting of the European Association for the Study of Diabetes (EASD) 2016 and also published in the New England Journal of Medicine.

The US Food and Drug Administration requires cardiovascular safety data for all diabetes drugs, after older drugs were found to have raised the risk of heart problems. Pharma companies have turned this to their advantage by producing medicines with a double effect of treating disease, and reducing cardiovascular events.