Jardiance prevails where Entresto could not

Right now the only drug approved for heart failure with preserved ejection fraction is Novartis’s Entresto – and only in some patients. This could be about to change, with Lilly and Boehringer Ingelheim reporting a topline win in HFpEF today with their SGLT2 inhibitor Jardiance. The companies are saving details of the Emperor-Preserved trial for the European Society of Cardiology meeting in August, and the magnitude of benefit will be closely watched. By way of comparison, Entresto showed a 13% reduction in the risk of cardiovascular death and heart failure hospitalisations; this narrowly missed statistical significance but was enough for the FDA to broaden that drug’s label. Hopes will now be building for a class effect with the SGLT2s in HFpEF; a benefit had already been suggested with Lexicon’s SGLT1/2 inhibitor sotagliflozin, while the Deliver trial of Astrazeneca’s Farxiga is set to complete early next year. Jardiance, currently marketed for type 2 diabetes, is forecast to sell over $5bn by 2026, according to Evaluate Pharma sellside consensus, but this might soon get a bump. Lilly and Boehringer do not have too long to benefit from any heart failure approvals, though, with the drug set to come off patent in 2028.  

Selected studies in HFpEF 
Product Company/ies HFpEF trial Data Note
Entresto Novartis Paragon 13% risk reduction in CV death & HHF, p=0.059 Approved for HF pts with LVEF "below normal"
Sotagliflozin  Lexicon Soloist & Scored Pooled analysis: 37% risk reduction in CV death, HHF & urgent HF visit, p=0.009 2021 filing planned in HF with T2D
Jardiance Lilly/Boehringer Emperor-Preserved Met primary endpoint of time to CV death or HHF; full data at ESC 2021 2021 filing planned in HFpEF; filed in HFrEF with decision due 2021
Farxiga Astrazeneca Deliver Completes Jan 2022 (prev Nov 2021) Approved in HFrEF in May 2020
Injectable sema 2.4mg Novo Nordisk Step-HFpEF in HFpEF & obesity* Completes Mar 2023  
Tirzepatide Lilly Summit in HFpEF & obesity Completes Nov 2023  
Finerenone  Bayer Finearts-HF in pts with EF ≥40% Completes Mar 2024  
*Second ph3 study planned in pts with obesity-related HFpEF & T2DM. HHF=hospitalisation for heart failure; LVEF=left ventricular ejection fraction; T2D=type 2 diabetes. Source: company releases & clinicaltrials.gov.

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