FDA approves Dapagliflozin for heart failure with reduced ej
Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...
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
Dr. A●●●●●l s●●●●a and 2 other likes this1 share
Like
Comment
Share