Farxiga gets Fast Track status from FDA


The Food and Drug Administration has given Fast Track designation to the development of dapagliflozin (Farxiga) to delay progression of renal failure and to prevent cardiovascular and renal death in patients with chronic kidney disease with and without type 2 diabetes, according to a release from AstraZeneca.

FDA icon

The Fast Track designation is meant to accelerate the development and review process for the treatment of serious conditions that have unmet therapeutic needs.

Dapagliflozin, an oral daily sodium-glucose transporter 2 inhibitor, is approved both as a monotherapy and a component of combination therapy for the improvement of glycemic control in patients with type 2 diabetes, according to the release. It is given as an adjunct to diet and exercise, and has also shown additional benefits of weight loss and reduction in blood pressure.

A phase 3, randomized, placebo-controlled trial, DAPA-CVD (NCT03036150), is currently underway to evaluate the drug’s efficacy specifically in terms of renal outcomes and cardiovascular mortality in patients with chronic kidney disease, with and without type 2 diabetes. Participants receive once-daily dapagliflozin or placebo in addition to standard care.

Taking dapagliflozin carries risks of hypotension, renal impairment, hypoglycemia, and other concerns. The most common adverse reactions (5% or greater incidence) include female genital mycotic infections, nasopharyngitis, and urinary tract infections. Full prescribing information can be found on the agency’s website.

Next Article: