AstraZeneca has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of Forxiga (dapagliflozin).
The designation is for the indication of delaying the progression of renal failure and prevent cardiovascular (CV) and renal death in patients with chronic kidney disease (CKD).
The drug, a first-in-class, oral once-daily SGLT2 inhibitor, has a robust programme of clinical trials that includes more than 35 completed and ongoing Phase IIb/III trials in more than 35,000 patients, as well as more than 2.5 million patient-years’ experience.
The Phase III DAPA-CKD clinical trial is currently underway to evaluate the effect of the treatment on renal outcomes and CV mortality in patients with CKD with and without type II diabetes versus placebo, on top of standard of care.
Earlier this month the company announced positive results from the Phase III DAPA-HF trial, in which Forxiga showed a statistically-significant and clinically-meaningful reduction of cardiovascular death or the worsening of heart failure.
The study is the first heart failure outcomes trial with an SGLT2 inhibitor investigating the treatment of heart failure in adults with HFrEF on top of standard of care to include those with and without type II diabetes.
Mene Pangalos, executive vice president of AstraZeneca said that the Fast Track designation is an “important step towards more quickly addressing unmet treatment needs in chronic kidney disease,” and that the company will “work closely with the FDA to explore the potential for Forxiga to improve outcomes for these patients.”
CKD is a serious, progressive condition defined by decreased kidney function. The most common causes of CKD are diabetes and hypertension and the disease affects an estimated 200 million adults globally.