Pushing for a new approval for SGLT2 med Farxiga in chronic kidney disease (CKD), AstraZeneca last year posted impressive data in its pivotal trial. Now, the FDA has accepted its CKD application and awarded a priority review, setting up a decision for the second quarter—and putting Farxiga even farther ahead of its would-be rivals.
In that trial, dubbed Dapa-CKD, AZ’s Farxiga plus standard of care cut the combined risk of worsening kidney function or death caused by cardiovascular or kidney problems by 39% over placebo in certain CKD patients. Plus, the drug cut the risk of death from any cause by 31%.
Originally approved to control blood sugar, Farxiga last year scored a class-first FDA nod to reduce the risk of major cardiovascular events in patients with heart failure—whether or not they have diabetes. Now, AstraZeneca is hoping to change the treatment paradigm in chronic kidney disease. Johnson & Johnson’s Invokana carries an FDA approval in diabetic kidney disease, but Farxiga is gunning for a nod in chronic kidney disease with or without type 2 diabetes.
When AZ presented its detailed phase 3 Dapa-CKD results back in August, an exec said the data “really has the potential to rewrite” medical textbooks. Before that, the company stopped its trial early last March after interim data “showed Farxiga's benefits earlier than originally anticipated.”
The FDA’s Wednesday move “brings us a step closer to delivering this new treatment option for the millions of patients living with chronic kidney disease in the U.S.,” AZ’s executive vice president of biopharma R&D, Mene Pangalos, said in a statement. “Farxiga has the potential to be a truly transformational medicine across a breadth of diseases, including type 2 diabetes, heart failure with reduced ejection fraction and, if approved, chronic kidney disease.”
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Meanwhile, Boehringer Ingelheim and Eli Lilly’s Jardiance scored an FDA fast track designation in chronic kidney disease last March. The partners are investigating the medicine as a treatment to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease.
Around 37 million people in the U.S. are estimated to have chronic kidney disease, AZ says, and the condition is expected to become the fifth-leading cause of mortality worldwide by 2040.