What is the new indication of Farxiga?
The FDA granted a new indication to dapagliflozin (Farxiga, AstraZeneca), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, to reduce the risk for sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease (ESKD), cardiovascular (CV) death and hospitalization for heart failure (HF) in …
Is Farxiga safe for kidneys?
Today, the U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression.
Is there a recall on Farxiga?
Has a Recall Been Issued? Farxiga has only been on the U.S. market a short time (approved in January 2014), and no recall has yet been issued for it or any other SGLT2 inhibitor diabetes drug. The FDA issues recalls only after medications are found to be defective or potentially harmful.
When was Farxiga kidney failure?
Around 37 million people in the U.S. are estimated to have CKD, and for many, medications are necessary to help prevent the condition from getting worse. At the end of April 2021, the FDA approved Farxiga (dapagliflozin), a diabetes medication, to also treat CKD.
What medication is comparable to Farxiga?
Jardiance and Farxiga have similar side effects and warnings, and they’re both taken once per day. The key difference between these drugs lies in the type of heart disease complications they’re approved to help prevent. Jardiance is approved to reduce the risk of death from heart attacks, stroke, and heart failure.
What medications improve ejection fraction?
They work by widening blood vessels. Examples of these drugs include the ACE inhibitors lisinopril (Zestril, Qbrelis, Prinivil), enalapril (Epaned, Vasotec), or captopril; the ARNI sacubitril-valsartan (Entresto), or the single agent ARBs like candesartan (Atacand), losartan (Cozaar) or valsartan (Diovan).
When was Farxiga heart failure?
In October 2019 the US FDA approved FARXIGA to reduce the risk of hospitalization for HF in adult patients with T2D and established CV disease or multiple CV risk factors.
How long has Farxiga been out?
Farxiga was originally approved in 2014 to treat type 2 diabetes. This medication helps lower your A1C — a number that represents your average blood sugar over the past 3 months — and is typically taken along with other diabetes medications like metformin (Glucophage).
Have there been any Invokana settlements?
Note: We are no longer taking Invokana and Invokamet cases. In October 2018, Johnson & Johnson and their subsidiary Janssen agreed to settle a large portion of the 1,000 Invokana lawsuits filed against them in a New Jersey multidistrict litigation (MDL).
Can Farxiga reverse kidney damage?
In August 2020, results from the DAPA-CKD Phase III trial demonstrated that Farxiga achieved unprecedented reduction in the composite risk of kidney failure and CV or renal death in patients with CKD with and without T2D versus placebo.
What drug can replace Januvia?
Alternatives to Januvia
- linagliptin (Tradjenta)
- metformin (Glucophage, Glucophage XR, Fortamet, Glumetza)
- empagliflozin (Jardiance)
- canagliflozin (Invokana)
- saxagliptin (Onglyza)
- alogliptin (Nesina)
- glipizide (Glucotrol and Glucotrol XL)
- sitagliptin and metformin hydrochloride (Janumet)
Is Farxiga approved in the US?
April 30, 2021 Today, the U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression.
What is the history of Farxiga?
Farxiga was originally approved in 2014 to improve glycemic control in adults with type 2 diabetes in addition to diet and exercise. Farxiga received Fast Track, Breakthrough Therapy and Priority Review designations for the indication being approved today.
What is Farxiga’s Fast Track status?
Farxiga received Fast Track, Breakthrough Therapy and Priority Review designations for the indication being approved today. Fast track is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
What is Farxiga used for?
The FDA found that taking Farxiga may “reduce the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression.” Farxiga has been approved as a treatment for type 2 diabetes since 2014.