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January 31, 2020

FDA frants AstraZeneca’s Farxiga review for treating heart failure

By GlobalData Healthcare

Earlier this month, the FDA provided AstraZeneca’s Farxiga (dapagliflozin) with a priority review, accepting a supplemental New Drug Application (sNDA) for reducing the risk of cardiovascular (CV) events in heart failure (HF) patients with reduced ejection fraction (HF-REF) with or without type 2 diabetes (T2D).

Due to the nature of the crowded and competitive sodium-glucose transport 2-inhibitor (SGLT2-I) class, the label expansion would provide Farxiga with an edge over rival SGLT2-Is such as Johnson & Johnson’s Invokana (canagliflozin) and Eli Lilly and Boehringer Ingelheim’s Jardiance (empagliflozin).

Currently, in the US Farxiga is approved to reduce the risk of hospitalisations in patients with HF-REF and T2D, as well as monotherapy or combination therapy for T2D. In September 2019, the FDA granted fast-track designation for Farxiga in HF-REF. It was dependent on results from an outcomes-based trial (DAPA-HF) that demonstrated Farxiga reduced the rate of hospitalisations by 36%.

Treatment with Farxiga was also shown to reduce the incidence of the composite outcome of CV death or worsening of heart failure by 26% when added to standard-of-care therapy for HF, according to Phase III DAPA-HF results presented in September 2019.

The Prescription Drug User Fee Act date is set for Q2 2020, providing the outcome as to whether or not Farxiga use in HF-REF will be approved. In addition, Farxiga has the potential to establish market dominance as a first-in-line therapy for T2D in patients with concomitant complications such as cardiorenal disease.

In August 2019, the FDA granted fast-track designation for Farxiga to reduce the progression of renal failure and prevent CV and renal death in patients with chronic kidney disease with or without T2D.

As CV and renal disease are of increasing incidence in the T2D patient population, GlobalData believes AstraZeneca’s Farxiga has significant potential to establish itself as a standard-of-care add-on therapy to treat T2D patients with specific comorbidities such as those with HF-REF.

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