- The Danish diabetes giant Novo Nordisk on Friday announced its type 2 diabetes drug Victoza reduced the risk of adverse cardiovascular (CV) events, boosting the drug's competitiveness against Eli Lilly/Boehringer Ingelheim's Jardiance.
- The much-anticipated CV benefits trial compared Victoza against a placebo and showed a statistically significant reduction in the risk of major adverse CV events among patients taking Victoza. The detail results of the LEADER trial will be presented in June 2016.
- More than 9,000 patients participated in the five-year study, Novo's largest and longest clinical trial to date.
The pressure has been on ever since Eli Lilly and Boehringer's Jardiance became the first diabetes drug with a demonstrated CV benefit. Results last year from a 7,000-patient trial showed Jardiance reduced the combined risk of hospitalization or death due to heart failure by 39%.
Novo did not release the details of its study (to be presented in June) so it is unclear how Victoza stacks up against Jardiance. In November, Novo managers had been uncertain whether LEADER would demonstrate superiority. Even a smaller but statistically significant CVD effect would help level the playing field between the two competing drugs.
"People with type 2 diabetes generally have a higher risk of experiencing major adverse cardiovascular events. That's why we are very excited about the results from LEADER," said Mads Krogsgaard Thomsen, chief science officer at Novo.
The five-year old Victoza pulled in roughly $2.7 billion in 2015 sales.
Recently, Novo's next-gen GLP-1 drug semaglutide has been on a roll, meeting headline objectives in five successful phase 3 trials, with one more to come. The successes help position semaglutide as an heir to Victoza. However, Sanofi also is working on a GLP-1 drug, using a priority review voucher on its LixiLan to speed up its review process.