Boehringer Ingelheim and Eli Lilly's Jardiance (empagliflozin) Receive the US FDA's Breakthrough Therapy Designation for the Treatment of Heart Failure with Preserved Ejection Fraction
Shots:
- The designation is based on the P-III EMPEROR-Preserved trial evaluates the safety and efficacy of empagliflozin (10mg- qd) vs PBO in 5-988 patients with chronic HFpEF with/out diabetes
- The results demonstrated a 21% reduction in risk for the composite 1EPs of CV death or hospitalization for adults with HF. The results were presented at ESC 2021 & published in NEJM
- Empagliflozin has previously received FTD from FDA to reduce the risk of CV death and hospitalization for HF & is approved for HFrEF with/out diabetes in the EU & US. Additionally- the companies plan for global regulatory submissions for HFpEF in 2021
Ref: Lilly | Image: Boehringer Ingelheim
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