- Less than a year after Boehringer Ingelheim and Eli Lilly demonstrated their diabetes treatment Jardiance reduced the risk of cardiovascular (CV) disease, the companies plan to initiate two new trials to study the drug's effect against chronic heart failure.
- Jardiance was the first drug to show a CV benefit in a dedicated outcomes trial, setting off a race among other drugmakers to show a similar benefit with their drugs.
- Boehringer and Lilly expect the trials to begin within the next 12 months and the studies will enroll chronic heart failure patients both with and without type 2 diabetes.
The studies announced on Tuesday will build on the breakthrough EMPA-REG outcome trial, which first demonstrated the CVD benefit of Jardiance.
Data from the 7,000-person study showed treatment with Jardiance reduced the risk of death due to CV disease by 38%, along with reducing the risk of hospitalization from heart failure. As people with diabetes are two to three times more likely to develop heart failure, demonstrating CV benefit is a significant edge in the competitive diabetes market.
"The EMPA-REG outcome trial demonstrated that Jardiance reduces the risk of cardiovascular death in diabetes patients at high CV risk, and we now look forward to exploring whether Jardiance can also provide heart failure benefits," said Hans-Juergen Woerle, global vice president medicine at Boehringer Ingelheim.
Danish company Novo Nordisk has been trying to make up ground since the original announcement from Boehringer and Lilly. In a much-anticipated CV outcomes trial, Novo's drug Victoza last month demonstrated a statistically significant reduction in the risk of major adverse CV events among patients taking the drug.
The company did not disclose detailed results when it announced the headline finding, so how Victoza's CV benefit stacks up compared to Jardiance is unclear. Further data is expected to be announced in June 2016.
Victoza is an older drug than Jardiance and pulled in about $2.7 billion in 2015 sales. Novo is developing its next-generation GLP-1 treatment semaglutide as a successor to Victoza, but faces competition from Sanofi's Lixilan.
Boehringer and Lilly share revenue from Jardiance as part of their diabetes alliance but have not disclosed the exact arrangement. Lilly's 2015 annual report indicated revenues from the drug as of December 31, 2015 were not significant.
However, Boehringer did drop one clue to its sales in a recently released annual report, saying Trajenta and Jardiance combined for sales of over €1 billion. The report indicated elsewhere that the Trajenta family of medicines pulled in €909 million in net sales last year, suggesting a general ballpark for Jardiance numbers so far.
Over 26 million people worldwide suffer from chronic heart failure, and roughly one-third of diabetes patients have the condition. About half of all patients die within five years, according to Boehringer. Further cementing the cardiovascular benefit of Jardiance will help the two companies match this acute medical need.