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Boehringer Ingelheim and Eli Lilly's Empagliflozin Receive FDA's Fast Track Designation for Chronic Heart Failure

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Boehringer Ingelheim and Eli Lilly's Empagliflozin Receive FDA's Fast Track Designation for Chronic Heart Failure

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  • The Fast Track designation follows two P-III EMPEROR-Reduced & EMPEROR-Preserved studies assessing Empagliflozin (qd) vs PBO in 8-500+ patients with heart failure with reduced & preserved ejection fraction- both with/without diabetes prior treated with SOC respectively
  • The two P-III EMPEROR-Reduced & Preserved studies will evaluate the safety & efficacy of empagliflozin with the 1EPs as the reduction in risk of cardiovascular death and hospitalization for heart failure with their expected completion in 2020
  • Jardiance (empagliflozin-qd) is an oral therapy used to lower the blood sugar level in adults with T2D and cardiovascular diseases and is contraindicated in patients with T1D and diabetic ketoacidosis

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Ref: Eli Lilly | Image: Eli Lilly


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