In July 2020, Eli Lilly and Boehringer Ingelheim’s (BI) sodium-glucose co-transporter-2 inhibitor (SGLT-2I), Jardiance (empagliflozin), successfully demonstrated the ability to reduce the risk of cardiovascular (CV) death and hospitalisation in patients who suffer from heart failure with reduced ejection fraction (HF-REF), with or without type 2 diabetes (T2D), in recent Phase III top-line results. Approximately 55% of T2D patients suffer from cardiovascular disease (CVD), which often leads to further complications such as major adverse cardiac events (MACE), including hospitalisation for HF, and diabetic nephropathy related to cardiorenal disease. If the EMPEROR-Reduced Phase III trial is able to demonstrate Jardiance has a strong safety profile for HF-PEF patients, and the drug receives FDA approval, this would strengthen the position of Eli Lilly and BI in the increasingly competitive SGLT-2I space.
The EMPEROR-Reduced Phase III trial met its primary endpoint of reducing the composite risk of CV death due to HF, with Jardiance demonstrating superiority versus placebo when added to the standard of care. A challenge for the SGLT-2I market will be to demonstrate a strong safety profile, from long-term data, for HF patients. Safety is of particular concern in those who are elderly, as the SGLT-2I drug class has several side effects including increased risk of lower limb amputation and urinary tract infections (UTIs). The top-line data from the EMPEROR trial have indicated that the safety profile was similar to the known safety profile from past Jardiance results.
Jardiance has previously demonstrated compelling CV data in T2D patients during the EMPA-REG OUTCOME trial, which has now been bolstered by the positive data from the EMPEROR-Reduced trial. During the Eli Lilly Q2 Investor presentation in early August, it was announced that the full results of the Phase III EMPEROR trial could be expected later this month at the European Society of Cardiology (ESC) conference. Outcomes for HF-PEF patients from the EMPEROR-PRESERVED study for HF patients are expected in 2021, in addition to the results for the chronic kidney study, EMPA-KIDNEY, to also be published in 2022. These additional studies are expected to demonstrate positive outcomes and lead to label updates, which will strengthen Jardiance’s position in the SGLT-2I market and enable the drug to be prescribed for a wider range of patients, including the rapidly growing population of T2D patients with complex CV-related comorbidities.
Key opinion leaders (KOLs) interviewed by GlobalData have expressed a preference for the use of SGLT-2Is for T2D patients who are presenting with CV-related comorbidities, such as HF, as they have observed that the class has positive cardiovascular outcomes. This is particularly the case for Europe, where the ESC has recommended SGLT-2Is as a first-line treatment for those with T2D and CVD. Eli Lilly and BI plan to file for regulatory approval in H2 2020, and if approved, Jardiance will be a direct competitor to AstraZeneca’s Farxiga (dapagliflozin), and gain a substantial share of the HF market, while also strengthening Eli Lilly’s and BI’s presence in the T2D market. GlobalData predicts that should Jardiance achieve regulatory approval, it along with Farxiga will likely constitute the main driver of growth for the branded HF treatment market.