The U.S. and German pairing of Eli Lilly ($LLY) and Boehringer Ingelheim has seen Jardiance do well as a Type 2 diabetes therapy--but now the two research partners are seeking to extend its reach into heart failure patients.
The duo said they are planning to conduct two outcome trials investigating their jointly marketed SGLT2 diabetes medicine for the treatment of people with chronic heart failure.
The studies are slated to start within the year, with plans to enroll people with chronic heart failure both with and without Type 2 diabetes.
The theory that it might work comes from the Big Pharmas’ previous testing of Jardiance, when in the Empa-reg outcome study in 2015, the drug became the first diabetes treatment to demonstrate a reduction in the risk of cardiovascular (CV) death.
This was demonstrated on top of standard of care (including glucose-lowering agents and CV drugs) in people with Type 2 diabetes, and who were at high risk of CV events.
In addition to reducing CV death by 38%, the Empa-reg outcome trial also showed that Jardiance reduced the risk of hospitalization for heart failure patients, according to the companies’ statement. These results led to the planned trials, the drugmakers said.
The study assessed the effect of the drug added to standard of care compared with placebo added to standard of care--where standard of care was comprised of glucose-lowering agents and CV drugs, including statins.
The primary endpoint was defined as time to first occurrence of CV death, non-fatal heart attack or non-fatal stroke. The study showed that over a median of 3.1 years, Jardiance significantly reduced the risk of CV death, non-fatal heart attack or non-fatal stroke by 14% versus placebo. Risk of CV death was also reduced by 38% with no significant difference in the risk of non-fatal heart attack or non-fatal stroke.
“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 Professor Hans-Juergen Woerle, global VP of medicine at Boehringer.
Heart failure is a prevalent disease with around 26 million people around the world and 5.7 million people in the U.S. suffering from chronic heart failure.
Novartis’ ($NVS) Entresto (LCZ696) is the most notable new HF drug to reach the market in the past year, and will likely be yard stick by which Lilly and Boehringer’s trials will be measured.
The treatment, approved by the FDA in July, could bring sales of $5 billion to $10 billion, according to analysts, based on its stellar trial results showing it can significantly reduce the rate of cardiovascular death and hospitalizations among thousands of patients with a particular form of heart failure.
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