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. https://www.evaluate.com/vantage/articles/news/snippets/jardiance-prevails-where-entresto-could-not | ||||
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