Janssen says FDA approves Invokana to treat DKD
The Janssen Pharmaceutical Companies of Johnson & Johnson announced earlier that the U.S. Food and Drug Administration approved a new indication for INVOKANA to reduce the risk of end-stage kidney disease, worsening of kidney function, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes and diabetic kidney disease with a certain amount of protein in the urine. INVOKANA is now the only type 2 diabetes medicine indicated to both treat diabetic kidney disease and reduce the risk of hospitalization for heart failure in patients with T2D and DKD. With the approval of these new uses, INVOKANA(R) is now the only diabetes medicine indicated to help type 2 diabetes patients reduce the risks associated with diabetic kidney disease, including hospitalization for heart failure," said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. "This significant advancement addresses serious unmet needs and could change the trajectory of care for the many millions of patients living with type 2 diabetes and diabetic kidney disease." The new indication is based on results from the landmark Phase 3 CREDENCE study in patients with T2D and DKD, which was stopped early because it met the prespecified criteria for efficacy.