Hot off the Press: FDA Approves New Treatment for Heart Failure with Reduced Ejection Fraction

On May 5, 2020 after receiving a Priority Review designation, the FDA announced a new indication for Farxiga (dapagliflozin) for adults of whom have heart failure with reduced ejection fraction to reduce the risk of cardiovascular death and hospitalizations for heart failure.  This approval makes Farxiga the first of its class, SGLT2 inhibitors, to be approved to treat adults with NYHA functional class II-IV heart failure with reduced ejection fraction. Other drugs in the SGLT2 inhibitors drug class include Invokana (canagliflozin) and Jardiance (empagliflozin). Farxiga also carries an indication to improve glycemic control in adults with T2DM in addition to diet and exercise. 

Farxiga’s safety and effectiveness was evaluated in a randomized, double-blind, placebo-controlled study that included 4,744 patients. The average age of the participants were 66 years and there was a greater presence of male patients (77%). Effectiveness was evaluated by looking at occurrence of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits. After 18 months of investigations, the study showed that those who received Farxiga had significantly better cardiovascular outcomes when compared to placebo. It is recommended that in Elderly patients, patients with renal insufficiency, those with low blood pressure and on diuretics should be assessed for their volume status and kidney function upon initiation of Farxiga. This is because SGLT2 inhibitors can cause dehydration, UTI’s and yeast infections. 

By: Maggie Vricos, PharmD Candidate 2021 

For the full article, visit: https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-type-heart-failure

For the updated package insert, visit: chrome-extension://oemmndcbldboiebfnladdacbdfmadadm/https://www.azpicentral.com/farxiga/farxiga.pdf#page=1

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