Janssen's Invokana Receives EU Approval for Diabetic Kidney Disease in Type 2 Diabetes Based on CREDENCE Trial Data
Johnson & Johnson
Healthcare Product Manufacturers, Health Service Providers
European Union
The European Union (German: Europäische Union; French: Union européenne), abbreviated as the EU, is headquartered in Brussels, the capital of Belgium. It evolved from the European Communities and originally had six founding member states: Germany, France, Italy, the Netherlands, Belgium, and Luxembourg. The Union currently has 28 member states and 24 official languages.In December 1991, the European Council meeting in Maastricht adopted the Treaty on European Union, commonly known as the Maastricht Treaty. On November 1, 1993, the Maastricht Treaty officially entered into force, marking the formal establishment of the European Union. In 2012, the EU was awarded the Nobel Peace Prize.Donald Tusk serves as President of the European Council, and Antonio Tajani is President of the European Parliament. Jean-Claude Juncker, former Prime Minister of Luxembourg, is President of the European Commission.The EU’s treaties have been amended multiple times, and its operations are governed by the Treaty of Lisbon. Politically, all member states are democracies (according to The Economist’s 2008 Democracy Index). Economically, it constitutes the world’s second-largest economic entity (with Germany, France, and Italy being members of the G8). Militarily, the vast majority of EU member states are also members of the North Atlantic Treaty Organization (NATO).
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Recently, Johnson & Johnson’s glucose-lowering drug Invokana (canagliflozin) was approved in the European Union for the treatment of diabetic kidney disease (DKD) in patients with type 2 diabetes (T2D). Its product label will include pivotal renal outcome data from the landmark CREDENCE trial. In Europe, Invokana is the first medication approved in nearly 20 years to slow the progression of DKD in patients with T2D, and it remains the only SGLT2 inhibitor approved for the treatment of DKD in this patient population.
The CREDENCE trial was the first renal outcomes study specifically conducted in adult patients with type 2 diabetes (T2D) and diabetic kidney disease (DKD). It enrolled a total of 4,401 patients with an estimated glomerular filtration rate (eGFR) of 30 to <90 mL/min/1.73 m² and proteinuria (urine albumin-to-creatinine ratio >300 to 5,000 mg/g). All patients were receiving standard background care for DKD.
The results showed that, compared with the placebo group, the Invokana group had a significant 30% reduction in risk for the primary composite endpoint (composite event rate: 43.2 vs. 61.2 per 1,000 patient-years; HR=0.70; 95% CI: 0.57–0.84; p<0.0001). The primary composite endpoint consisted of end-stage renal disease (ESRD), doubling of serum creatinine, and renal or cardiovascular (CV) death.
Regarding safety, the incidence of adverse events and serious adverse events was similar between the Invokana group and the placebo group, with no statistically significant differences in the rates of lower-limb amputation (HR=1.11) or adjudicated fractures (HR=0.98). Compared with the placebo group, the risk of diabetic ketoacidosis was small but increased in the Invokana group (HR=10.80; ARR: an increase of 2.0 events per 1,000 patient-years).
Invokana is a member of the SGLT2 inhibitor class, which acts independently of insulin. SGLT2 is a transporter protein involved in glucose reabsorption in the proximal renal tubules of the kidney. By inhibiting SGLT2 expressed in the kidneys, Invokana reduces renal glucose reabsorption and increases urinary glucose excretion, thereby lowering blood glucose levels. In Europe, Invokana was approved for marketing in 2013 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D).
Patients with diabetes are five times more likely to require dialysis or kidney transplantation than those without diabetes. Diabetes is the leading cause of renal failure. Therefore, slowing the progression of diabetic kidney disease (DKD) is critical to the successful management of type 2 diabetes and its known comorbidities.
The impressive results from the CREDENCE study have significant clinical implications for preventing kidney failure. These data have now been incorporated into major global guidelines for the treatment of kidney disease, diabetes, and cardiovascular conditions, offering an opportunity to improve health outcomes for millions of patients with chronic kidney disease and type 2 diabetes.
Reference Source: Napp Pharmaceuticals Announces European Commission Approval of Invokana (canagliflozin) Label Update to Reflect Improved Renal Outcomes in Patients With Diabetic Kidney Disease and Type 2 Diabetes
*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.