- In August, new data from Eli Lilly and Boehringer Ingelheim (BI) showing that Jardiance (empagliflozin) decreases risk of cardiovascular (CV)-related events and deaths, was announced.
- This news has put pressure on other diabetes drug makers to show a CVD benefit in their clinical trials.
- Novo Nordisk is currently conducting a CVD study, known as LEADER, for its big-selling GLP-1 drug Victoza.
Victoza, a GLP-1 analog, generated $2.4 billion in sales in 2014. Although Novo Nordisk managers are not assuming that LEADER will demonstrate superior CVD results, they are hoping that Victoza will demonstrate some CVD upside in the study.
"I cannot guarantee anything," said Novo's Chief Science Officer Mads Krogsgaard Thomsen in an interview with Reuters. "It will be very exciting.
"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."
One of the concerns is that the patients in the trial may too sick to enjoy any CV-related benefit, especially considering the fact that Victoza is often used as a third- or fourth-line option in patients with diabetes who were not able to achieve glycemic control with other treatment options.
Results are expected by the end of Q1 2016, and will be presented at next year's American Diabetes Association's annual meeting.
Companies that make SGLT2 inhibitors such as Jardiance, inlcuding Johnson & Johnson, have said that they believe there will be a class-wide CVD benefit demonstrated in such drugs. You can read our feature on the staggering amount of innovation going on in the diabetes field here.