The U.S. FDA (Food & Drug Administration) has recently approved an oral tablet, Farxiga, to treat adults with reduced ejection fraction. The tablet will significantly lower the risk of hospitalization due to heart failure as well as cardiovascular death.
Heart failure is a serious health condition that occurs when the left ventricle, which is the main pumping chamber, is weakened. Farxiga is the 1st among this drug class, SGLT2 (sodium-glucose co-transporter 2) inhibitors, to be approved by the FDA for treating adults with functional class II-IV heart failure of New York Heart Association. It reportedly contributes to 1 out of 8 deaths in the United States, impacting around 6.5 million Americans.
The effectiveness and safety of Farxiga had been evaluated in a double-blind, randomized, placebo-controlled clinical trial of 4,744 participants. These participants were assigned randomly for a dose of either 10 mg of a placebo or Farxiga, daily. To determine the effectiveness of the drug, the investigators inspected the occurrence of hospitalization, urgent heart failure visits, and cardiovascular death. Following the 18 months of consumption, there have been reductions in deaths, urgent visits and hospitalization of patients who received Farxiga than those who received the placebo.
The side-effects of the drug include genital yeast infections, serious urinary tract infections, and dehydration. The drug, when combined with insulin, can cause necrotizing fasciitis of the perineum among the low blood sugar and diabetic patients. Patients with low blood pressure and kidney problems, those on diuretics as well as elderly patients should be assessed for the kidney function and volume status. Patients showing signs of ketoacidosis or metabolic acidosis should also be assessed.
The application obtained a priority review designation, which means the agency planned to take action within 6 months. This is because the drug, if approved, would significantly enhance the effectiveness and safety for preventing, diagnosing, and treating a serious health condition.