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FARXIGA Granted FDA Priority Review For Patients With Heart Failure With Reduced Ejection Fraction

January 6, 2020 GMT

WILMINGTON, Del.--(BUSINESS WIRE)--Jan 6, 2020--

AstraZeneca today announced the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for FARXIGA ® (dapagliflozin) to reduce the risk of cardiovascular (CV) death or the worsening of heart failure (HF) in adults with heart failure with reduced ejection fraction (HFrEF) with and without type 2 diabetes (T2D).

The Prescription Drug User Fee Act date, the FDA action date for this supplemental application, is scheduled for the second quarter of 2020.

The sNDA was based on results from the landmark Phase III DAPA-HF trial published in September 2019 in The New England Journal of Medicine, which showed FARXIGA on top of standard of care reduced the incidence of the composite outcome of CV death or the worsening of HF versus placebo. FARXIGA is not indicated to reduce the risk of hospitalization for heart failure (hHF) in patients without diabetes, or to reduce the risk of CV death.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “FARXIGA is well established in the treatment of type 2 diabetes and this Priority Review shows its potential to also impact millions of patients with heart failure. If approved, FARXIGA will be the first and only medicine of its kind indicated to treat patients with heart failure.”

In September 2019, the FDA granted Fast Track designation for the development of FARXIGA in HF. In August 2019, the FDA also granted Fast Track designation for the development of FARXIGA to delay the progression of renal failure and prevent CV and renal death in patients with chronic kidney disease, with and without T2D.

FARXIGA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D. In October 2019, the FDA also approved FARXIGA to reduce the risk of hospitalization for heart failure in patients with T2D and established cardiovascular disease or multiple CV risk factors.

Indication and Limitations of Use for FARXIGA ® (dapagliflozin) tablets

FARXIGA is indicated:

FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

Important Safety Information for FARXIGA ® (dapagliflozin) tablets

Contraindications

Warnings and Precautions

Increases in serum creatinine and decreases in eGFR may be observed with initiation of FARXIGA. Elderly patients and patients with impaired renal function may be more susceptible to these changes. Consider temporarily discontinuing in settings of reduced oral intake or fluid losses

Before initiating FARXIGA, evaluate renal function and monitor periodically. FARXIGA is not recommended when the eGFR is <45 mL/min/1.73 m 2

Adverse Reactions

In a pool of 12 placebo-controlled studies, the most common adverse reactions (≥5%) associated with FARXIGA 5 mg, 10 mg, and placebo respectively were female genital mycotic infections (8.4% vs 6.9% vs 1.5%), nasopharyngitis (6.6% vs 6.3% vs 6.2%), and urinary tract infections (5.7% vs 4.3% vs 3.7%).

Use in Specific Populations

Please see accompanying US Full Prescribing Information and Medication Guide for FARXIGA.

NOTES TO EDITORS

About DAPA-HF

DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure) is an international, multicenter, parallel group, randomized, double-blind trial in patients with heart failure and reduced ejection fraction (LVEF ≤ 40%), with and without T2D, designed to evaluate the effect of FARXIGA 10mg, compared with placebo, given once daily in addition to standard of care. The primary composite outcome was time to a worsening heart failure event (hospitalization or equivalent event; i.e. an urgent heart failure visit), or cardiovascular death.

The full results of the DAPA-HF trial were published in The New England Journal of Medicine in September 2019.

About heart failure

Heart failure (HF) is a life-threatening disease in which the heart cannot pump enough blood around the body. It affects approximately 64 million people worldwide (at least half of which have a reduced ejection fraction) and is a chronic and degenerative disease where half of patients will die within five years of diagnosis. HF remains as ‘malignant’ as some of the most common cancers in both men (prostate and bladder cancers) and women (breast cancers). It is the leading cause of hospitalization for those over the age of 65 and represents a significant clinical and economic burden.

About AstraZeneca in CV, Renal & Metabolism (CVMD)

CV, renal and metabolism together form one of AstraZeneca’s main therapy areas and a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. Our ambition is to modify or halt the natural course of CVMD diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and CV health for millions of patients worldwide.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.

US-35445 Last Updated 1/20

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PUB: 01/06/2020 07:00 AM/DISC: 01/06/2020 07:01 AM

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