Boehringer Ingelheim and Eli Lilly have unveiled plans for two outcome trials investigating diabetes drug Jardiance for the treatment of chronic heart failure.
The trials should begin within the next 12 months and are planned to enroll people with chronic heart failure both with and without type II diabetes.
The firms note that Jardiance (empagliflozin) was the first diabetes treatment to demonstrate a reduction in the risk of cardiovascular death in a dedicated cardiovascular outcomes trial, on top of standard of care in diabetes patients at high risk of cardiovascular events.
As well as cutting cardiovascular death by 38 percent, the EMPA-REG OUTCOME trial also showed that Jardiance slashed the risk of hospitalisation for heart failure, spurring plans for the new trials.
"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, Boerginer’s global vice president medicine.
Twenty-six million people around the world and 5.7 million people in the US have chronic heart failure. Given that, despite available treatments, one in two die within five years of diagnosis, “there is currently a compelling need for an effective therapy to treat those suffering from this condition," noted Javed Butler, a cardiologist at Stony Brook University Hospital.
BI posts 11% rise in sales
Meanwhile, Boehringer has posted and 11 percent rise in sales and 6 percent jump in operating profit for 2015, driven by its diabetes portfolio, which showed “substantial growth” of around 49 percent to 1.1 billion euros.
Full-year operating profit climbed to 2.3 billion euros as sales hit 14.8 billion euros, Germany’s second-biggest drugmaker said.
Respiratory drug Spiriva (tiotropium) remained the firm’s best-selling product, generating net sales of over 3.5 billion euros in 2015, while blood thinner Pradaxa (dabigatran etexilate) pulled in 1.3 billion euros and lung drug Ofev (nintedanib) rose to almost 300 million euros.