Wednesday, August 4, 2021

Farxiga fails to achieve statistical significance in COVID-19 trial

AstraZeneca (AZ) announced this morning that its diabetes drug Farxiga was unable to hit the primary endpoints in a Phase III trial assessing the drug for the potential treatment of high-risk hospitalised COVID-19 patients.

The DARE-19 trial was evaluating the efficacy and safety of Farxiga (dapagliflozin) plus local standard of care therapy in adults hospitalised with COVID-19.

Patients enrolled in this trial also had a medical history of hypertension (HTN), type 2 diabetes (T2D), atherosclerotic cardiovascular disease (ASCVD), heart failure (HF) or chronic kidney disease (CKD) Stages 3-4.

Farxiga did not hit the primary endpoint of prevention measuring organ dysfunction and all-cause mortality, as well as the primary endpoint of recovery measuring a change in clinical status at 30 days.

“Prior to the DARE-19 Phase III trial, there was little data on the use of SGLT2 inhibitors in hospitalised patients with COVID-19 and we have now helped to fill this knowledge gap. We look forward to the efficacy and safety data being presented in the coming weeks,” Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AZ.

Outside of COVID-19, Farxiga is used to improve glycemic control in adults with T2D, and also became the first SGLT2 inhibitor approved for the treatment of heart failure with reduced ejection fraction (HFrEF) in adults with and without T2D.

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