The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial
Empagliflozin is a novel sodium glucose co-transporter-2 (SGLT-2) inhibitor, which is useful for improving glycaemic control in adults with type-2 diabetes mellitus.
Phase III trial also demonstrated a statistically significant reduction (14%) in hospitalization for any cause, bringing potential relief for patients and reducing burden on healthcare systems
With the approval from the Central Drugs Standard Control Organisation (CDSCO), Jardiance is now the first approved therapy to improve outcomes for the full spectrum of heart failure regardless of ejection fraction
R&D investment up 11.7% to 4.1 billion EUR in 2021 (20.0% of net sales)
The breakthrough approval expands the existing indication of Jardiance to include adults with heart failure with preserved ejection fraction (HFpEF), an underserved patient population that previously had no approved therapies in Europe
Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death or hospitalization for heart failure, regardless of ejection fraction
Jardiance is the first SGLT2-inhibitor therapy to prove reduction in risk of cardiovascular death in people with type-II diabetes and established cardiovascular disease
The company claims that its Empagliflozin tablets are the most affordable in India
The listings aim to address global health priorities, identifying the medicines that provide the greatest benefits, and which should be available and affordable for all
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