Farxiga’s time to get cardiologists on board

Astrazeneca’s Farxiga yesterday became the first SGLT2 inhibitor to get FDA approval for adults with heart failure with reduced ejection fraction. The green light was based on the Dapa-HF trial, which evaluated both patients with and without diabetes, and showed Farxiga achieving a statistically significant reduction of CV death or hospitalisation for heart failure, compared with placebo. Competition, however, isn’t far behind with Lilly and Boehringer’s own SGLT2 inhibitor, Jardiance, the biggest threat. Jardiance’s Emperor-Reduced study, analogous to Dapa-HF, has a primary completion date in June. But extending the use of SGLT2s doesn’t stop here: both Farxiga and Jardiance are undergoing outcomes trials in the tricky setting of heart failure with preserved ejection fraction. There are currently no approved treatments for this indication and many projects, including Novartis’s Entresto, have failed here; last month Bayer quietly terminated the phase II Vitality trial of vericiguat in this setting, presumably because the study failed.