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.

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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.