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March 16, 2022

Eli Lilly and Boehringer Ingelheim’s Jardiance gains heart failure approval from EU

There is an urgency to gain approval for the treatment of HF across the SGLT2-I class, which includes Jardiance (empagliflozin).

By GlobalData Healthcare

Eli Lilly and Boehringer Ingelheim (BI) has gained another significant approval, for heart failure (HF) treatment, this time from the EU, with regards to their sodium-glucose co-transporter-2-inhibitor (SGLT2-I), Jardiance (empagliflozin). Having previously gained a label expansion for Jardiance to treat HF in the US, Lilly and BI have now achieved the approval in the EU to treat adults with symptomatic chronic HF. Specifically, Jardiance can be used for preserved ejection fraction (HFpEF), which adds to the last year’s EU approval for Jardiance to treat patients with reduced ejection fraction (HFrEF). This will likely enable Jardiance to become a significant rival, in terms of market share, to Astrazeneca’s Farxiga (dapagliflozin), which has achieved approval for HFrEF previously.

As the competition for dominance in the HF market increases, there is an urgency to gain approval for the treatment of HF across the SGLT2-I class, which has traditionally been prescribed for type 2 diabetes (T2D). Key opinion leaders (KOLs) interviewed by GlobalData have reported their enthusiasm for the approval of SGLT2-Is for the treatment of HF following clinical data demonstrating significant benefit of these inhibitors, especially in patients suffering from both T2D and HF.

There are major challenges around the treatment of HFpEF, which is often characterized as a significant unmet need in cardiovascular medicine, as it has a significant prevalence and limited treatment options that often lead to poor outcomes. In HFrEF, systolic dysfunction occurs, whereas in HFpEF, the cardiac muscles contract appropriately but the thickening of the cardiac muscle leads to the left ventricle holding an abnormally small volume of blood.

Jardiance is now approved to address both indications of HF, with this EU approval being achieved several weeks after the FDA approved Jardiance for reducing risk of cardiovascular death and hospitalization in patients with HF regardless of left ventricular ejection fraction status. Successful results from the EMPEROR-Preserved study demonstrated that Jardiance reduced the risk of cardiovascular death or hospitalization for HF by 21% regardless of a patient’s ejection fraction or diabetes status.

AstraZeneca’s Farxiga is likely to suffer serious competition to its market share in the HF space as an increasing number of adults are diagnosed with HF. However, the increasing prevalence of HF is interlinked with chronic kidney disease (CKD) and T2D, and Farxiga is approved to treat CKD in addition to HF in patients with or without T2D, offering an additional advantage over Jardiance.

It is likely that Jardiance will capture an increased market share in the EU for the treatment of HF, with or without T2D, with this share increasing once Lilly and BI are also able to determine its efficacy for treating CKD, which is currently in Phase III trials. GlobalData expects Jardiance to become a leading SGLT2-I in the HF market, potentially overtaking Farxiga as the leading HF therapy, and to continue to be a leading therapeutic for patients with T2D and HF.

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