AstraZeneca put the rest of the SGLT2 inhibitor class on notice when its Farxiga scored an FDA heart failure nod in patients with or without diabetes. One of its competitors, Eli Lilly and Boehringer Ingelheim's Jardiance, is fast on Farxiga's heels, though, and it's ready to bring its pivotal trial win in front of physicians.
Jardiance, added to standard of care therapy, sliced the risk of cardiovascular hospitalizations or death by 25% over placebo in heart failure patients with or without Type 2 diabetes, according to late-breaking science set to be presented Saturday at the European Society of Cardiology virtual annual meeting.
The full data from the phase 3 Emperor-Reduced trial comes just weeks after the drugmakers declared a top-line win in their pursuit of SGLT2 rival Farxiga, which scored the class' first FDA approval in that indication back in May.
Once-daily Jardiance not only cut the risk of those CV events after 16 months, but it also reduced the average number of total hospitalizations in trial patients by 30% over placebo and improved kidney function by 50%.
Roughly half of the study's 3,730 heart failure patients with a reduced ejection fraction (HFrEF) didn't have Type 2 diabetes, and the partners saw consistent results regardless of a diabetes diagnosis.
With their regulatory filing planned, Lilly and Boehringer face a tough task in taking their drug into a market pioneered just months ago by Farxiga.
In the meantime, the partners are laying the groundwork with physicians to help connect the treatment of diabetes with other cardiometabolic outcomes, according to Dr. Mohamed Eid, Boehringer's vice president of clinical development and medical affairs for cardio-metabolism and respiratory medicine
"When we talk about heart failure, the incidence is on the rise and some of this is connected with diabetes," Eid said. "We really strongly encourage this approach of multidisciplinary study on interconnected pathologies."
Jardiance is contending with more than just Farxiga's head start; the diabetes med could face pushback from cardiologists who are unfamiliar with the SGLT2 class in heart failure and are attached to older medicines.