FDA fast-tracks BI, Lilly's Jardiance in chronic heart failure

When Boehringer Ingelheim and Eli Lilly’s diabetes med Jardiance first showed CV benefits in trial patients, it changed the game for the SGLT2 inhibitor class. Now, not content to rest on its laurels, Jardiance is going after an indication in chronic heart failure—and the FDA just sped up the process.

The FDA Wednesday slapped its Fast Track designation on the drug as a treatment for reducing the risks of cardiovascular death and hospitalization for heart failure among chronic heart failure patients. The agency reserves the designation, which will help facilitate an expedited review and possible future approval, for novel therapies in areas of unmet clinical need, Boehringer said in a release.

The move applies to two ongoing studies, dubbed Emperor-Reduced and Emperor-Preserved, which between them include more than 8,500 heart failure patients from a pool that could count up to 6.5 million in the U.S. and 26 million globally, according to Boehringer.

"Heart failure contributes to one in nine deaths and is a leading cause of hospitalization in the U.S., yet there are limited treatment options for people living with this debilitating disease," Mohamed Eid, Boehringer’s VP of clinical development, said in a statement. "We look forward to working closely with the FDA as we explore the potential for (Jardiance) to improve outcomes for adults with chronic heart failure."

Jardiance set itself apart in the SGLT2 class after its landmark Empa-Reg study from 2015 showed a 14% reduced risk of major CV events in Type 2 diabetes patients and established a new frontier for diabetes meds. The drug went on to win label update, clearing its makers to talk up its ability to slash diabetes patients' risk of cardiovascular death.

Since then, Jardiance has succeeded where other drugs in Boehringer’s portfolio have faltered. The Jardiance family, which also includes combos Synjardi and Glyxambi, posted a 52.5% increase in 2018 sales to hit $2.03 billion. Meanwhile, Boehringer’s overall revenues dropped 3.3% on the year, driven in part by COPD med Spiriva’s 11.4% sales slide.

Even as Jardiance has ridden its first-of-its-kind wave in CV, other SGLT2 competitors, AstraZeneca’s Farxiga and Johnson & Johnson’s Invokana, have sought to repeat Boehringer and Lilly’s success.

In March, phase 3 trial data for Farxiga showed a 16% cut in follow-up CV events in patients with diabetes. For trial patients with a reduced ejection fraction, the rate of hospitalizations was 36% lower for those using Farxiga versus those taking placebo and 24% lower for patients without a reduced ejection fraction. The drug has yet to receive an FDA nod for its CV benefits.

But a drug that has succeeded in nabbing a CV label expansion is Invokana, which received its FDA approval in October for reducing major CV events in high-risk Type 2 diabetes patients. That particular approval is one of a kind, but Invokana—which bears a label warning for amputation risks—is still playing catch-up with Jardiance.