Novo Nordisk is considering options ahead of key heart safety data for its diabetes drug Victoza and could run a further clinical study if necessary, the Danish company’s research head said on Wednesday.

The outcome of Novo’s current cardiovascular trial, known as LEADER, has become critical following the unprecedented success of Eli Lilly and Boehringer Ingelheim’s Jardiance pill in slashing deaths in diabetics with heart risk.

Headline results from LEADER are expected by the end of the first quarter of 2016, with full results likely to be presented at the American Diabetes Association annual meeting in June.

Industry analysts say the success of Jardiance has increased the pressure on Novo to prove its drug can also cut the danger of heart attacks and strokes, since cardiovascular problems are major risks for people with diabetes.

Chief Science Officer Mads Krogsgaard Thomsen is convinced Victoza, a so-called GLP-1 drug that sold $2.4 billion in 2014, does have heart benefits. But he’s not certain if these will be apparent in the relatively sick patients enrolled in LEADER.

“I cannot guarantee anything. It will be very exciting,” he told Reuters during a visit to London.

“We are preparing ourselves for different scenarios. If it is borderline, what I would strongly consider is doing another study. We are already doing the exercise to work out what kind of study we would do and with what kind of patients.”

Thomsen said current financial forecasts did not assume that Victoza would demonstrate superiority in LEADER, so a positive result would represent pure upside by encouraging greater use.

Many analysts, however, believe a failure would weigh on Victoza sales by delaying its use.

Novo’s injectable drug is currently typically prescribed as a third or fourth option after patients have first tried various oral medicines.

Jardiance belongs to a new family of treatments called SGLT2 inhibitors that also include Johnson & Johnson’s Invokana and AstraZeneca’s Farxiga. Those rival drugs have not yet shown the same heart benefits.


(Editing by Adrian Croft)

Source: Reuters Health