Pharma looking to dual-action diabetes drugs to boost sales

Diabetes drugs with a dual action of treating the disease, while also reducing risk of cardiovascular events, are becoming increasingly important to pharma companies, as new data emerges about key medicines.

The US regulator asks for cardiovascular safety data for all diabetes drugs as they are often taken for long periods of time.

But pharma companies have learnt to use this to their advantage and are now using clinical trials required by the US Food and Drug Administration to make the case to doctors and payers that their medicines could be used in a wider group of patients thanks to this dual action.

For instance, in September Boehringer Ingelheim/Lilly’s Jardiance (empagliflozin), which has a different mechanism of action, showed a cardiovascular benefit in type 2 diabetes in a clinical trial late last year.

And a new analysis of data from the EMPA-REG OUTCOME trial has shown Jardiance, reduced risk across age groups for cardiovascular outcomes, including cardiovascular death compared with placebo when added to standard of care in adults with type 2 diabetes and established cardiovascular disease.

Novo Nordisk is due to announce cardiovascular data about its already marketed GLP-1 Victoza (liraglutide) from the LEADER-1 trial later today at the American Diabetes Association Scientific Sessions (ADA) conference in New Orleans.

In March the Danish pharma said the cardiovascular safety trial had met primary endpoints - but this will be the first time details have been published.

Jacob Riis, Novo’s executive vice president for China, Pacific and marketing, told pharmaphorum that the company’s next-generation, weekly GLP-1 injection semaglutide is even more important to the company.

Top-line data from the SUSTAIN6 trial shows that it too produces a statistically significant reduction in cardiovascular risk – and data is due out later this year after encouraging results on glycaemic control versus two rivals were announced at ADA.

Victoza is currently used in patients where other treatments have failed – but Novo hopes the cardiovascular data could convince payers such as NICE to use the drug before disease progresses because of this dual benefit.

Novo is continuing to work towards a regulatory filing of semaglutide later this year. The company is also working on a daily injected version of the drug.

Riis wouldn’t comment on sales targets for the semaglutide, but Novo clearly thinks there is untapped potential in the GLP-1 market, despite competition from companies such as Sanofi with Lyxumia (lixisenatide), or AstraZeneca’s Byetta (exenatide).

Riis said: “We believe that the (GLP-1) market is very far from being saturated. We have high hopes for expansion of the GLP 1 side of our profile, particularly semaglutide.”