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.
Looking beyond diabetes with the SGLT2 inhibitors | |||
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Trial name | Setting | Trial ID | Note/primary completion date |
Farxiga (Astrazeneca) | |||
Dapa-HF | CV outcomes in HF with reduced EF | NCT03036124 | FDA approval May 5, 2020 |
Dapa-CKD | Cardiorenal outcomes in CKD | NCT03036150 | Halted for efficacy Mar 2020 |
Determine-reduced | HF symptoms in pts with reduced EF | NCT03877237 | Mar 2020 |
Determine-preserved | HF symptoms in pts with preserved EF | NCT03877224 | Jul 2020 |
Deliver | CV outcomes in HF with preserved EF | NCT03619213 | Jun 2021 |
Jardiance (Eli Lilly/Boehringer Ingelheim) | |||
Emperial-Reduced | HF symptoms in pts with reduced EF | NCT03448419 | Failed Dec 2019 |
Emperial-Preserved | HF symptoms in pts with preserved EF | NCT03448406 | Failed Dec 2019 |
Emperor-Reduced | CV outcomes in HF with reduced EF | NCT03057977 | Jun 2020 |
Emperor-Preserved | CV outcomes in HF with preserved EF | NCT03057951 | Oct 2020 |
Empa-Vision | Heart function in HF patients | NCT03332212 | May 2020 |
Empa-Kidney | Cardiorenal outcomes in CKD | NCT03594110 | Jun 2022 |
EF=ejection fraction. CKD=chronic kidney disease. Source: EvaluatePharma, clinicaltrials.gov. |