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US FDA approved Farxiga (dapagliflozin) oral tablets for adults with heart failure with reduced ejection fraction to reduce the risk of cardiovascular death and hospitalization for heart failure.
• Farxiga is the first in the drug class of sodium-glucose co-transporter 2 (SGLT2) inhibitors, approved for the treatment of adults with heart failure.
• Farxiga was shown in a clinical trial to improve survival and reduce the need for hospitalization in adults with heart failure with reduced ejection fraction.
• Safety and effectiveness were evaluated in a randomized, double-blind, placebo-controlled study of 4,744 participants. The average age of participants was 66 years and more participants were male (77%) than female.
• Participants were randomly assigned to receive a once-daily dose of either 10 milligrams of Farxiga or a placebo (inactive treatment).
• After about 18 months, people who received Farxiga had fewer cardiovascular deaths, hospitalizations for heart failure, and urgent heart failure visits than those receiving the placebo.
• Side effects: Dehydration, serious urinary tract infections, genital yeast infections, serious cases of necrotizing fasciitis of the perineum (Fournier’s Gangrene) in people with diabetes & low blood sugar when combined with insulin.
Farxiga is also FDA-approved to improve glycemic control in adults with type 2 diabetes in addition to diet and exercise and to reduce the risk of hospitalization for heart failure among adults with type 2 diabetes and known cardiovascular disease or other risk factors.
The FDA granted the approval of Farxiga related to heart failure to AstraZeneca Pharmaceuticals LP Wilmington, DE.
Source: https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-type-heart-failure
• Farxiga is the first in the drug class of sodium-glucose co-transporter 2 (SGLT2) inhibitors, approved for the treatment of adults with heart failure.
• Farxiga was shown in a clinical trial to improve survival and reduce the need for hospitalization in adults with heart failure with reduced ejection fraction.
• Safety and effectiveness were evaluated in a randomized, double-blind, placebo-controlled study of 4,744 participants. The average age of participants was 66 years and more participants were male (77%) than female.
• Participants were randomly assigned to receive a once-daily dose of either 10 milligrams of Farxiga or a placebo (inactive treatment).
• After about 18 months, people who received Farxiga had fewer cardiovascular deaths, hospitalizations for heart failure, and urgent heart failure visits than those receiving the placebo.
• Side effects: Dehydration, serious urinary tract infections, genital yeast infections, serious cases of necrotizing fasciitis of the perineum (Fournier’s Gangrene) in people with diabetes & low blood sugar when combined with insulin.
Farxiga is also FDA-approved to improve glycemic control in adults with type 2 diabetes in addition to diet and exercise and to reduce the risk of hospitalization for heart failure among adults with type 2 diabetes and known cardiovascular disease or other risk factors.
The FDA granted the approval of Farxiga related to heart failure to AstraZeneca Pharmaceuticals LP Wilmington, DE.
Source: https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-type-heart-failure
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