Farxiga’s time to get cardiologists on board

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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
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.

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