EUROPE – Eli Lilly and Boehringer Ingelheim (BI) have received another significant approval, this time from the European Union (EU), for their sodium-glucose co-transporter-2-inhibitor (SGLT2-I), Jardiance (empagliflozin).

Eli Lilly and Boehringer Ingelheim’s Type 2 diabetes medicine, Jardiance has been shown to reduce the risk of death and hospitalization from heart failure in patients with preserved ejection fraction (HFpEF).

Following the approval of Jardiance for the treatment of heart failure (HF) in the United States, Lilly and BI have now received approval in the European Union to treat adults with symptomatic chronic HF.

Jardiance can now be used to treat patients with preserved ejection fraction (HFpEF), which adds to Jardiance’s previous EU approval to treat patients with reduced ejection fraction (HFrEF).

This will most likely allow Jardiance to become a significant market share rival to Astrazeneca’s Farxiga (dapagliflozin), which has previously received approval for HFrEF.

Rising competition in heart failure market

As competition for dominance in the heart failure market heats up, there is a pressing need to obtain approval for the treatment of heart failure across the SGLT2-I class, which has traditionally been prescribed for type 2 diabetes (T2D).

There are significant challenges in treating HFpEF, which is often characterized as a significant unmet need in cardiovascular medicine due to its high prevalence and limited treatment options, which frequently result in poor outcomes.

Systolic dysfunction occurs in HFrEF, whereas in HFpEF, the cardiac muscles contract normally, but thickening of the cardiac muscle causes the left ventricle to hold an abnormally small volume of blood.

Jardiance is now approved to treat both indications of heart failure, with the EU approval coming just a few weeks after the FDA approved Jardiance for lowering the risk of cardiovascular death and hospitalization in patients with heart failure regardless of left ventricular ejection fraction status.

The EMPEROR-Preserved study found that Jardiance reduced the risk of cardiovascular death or hospitalization for HF by 21% regardless of the patient’s ejection fraction or diabetes status.

As an increasing number of adults are diagnosed with HF, AstraZeneca’s Farxiga is likely to face stiff competition for its market share in the heart failure space.

 However, the rising prevalence of heart failure is linked to chronic kidney disease (CKD) and type 2 diabetes (T2D).

Farxiga is approved to treat CKD in addition to heart failure in patients with or without T2D, providing an advantage over Jardiance.

Jardiance is expected to gain a larger market share in the EU for the treatment of HF, with or without T2D, with this share growing once Lilly and BI determine its efficacy for treating CKD, which is currently in Phase III trials.

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