Swiss Vifor Pharma has entered a commercial partnership with Janssen Pharmaceuticals, part of the Janssen Pharmaceutical Companies of Johnson & Johnson, to jointly commercialise INVOKANA (canagliflozin) in the US. This drug treats DKD and reduces the risk of hospitalisation for heart failure in patients with type 2 diabetes and diabetic kidney disease.
INVOKANA is already available in the US to reduce the risk of major cardiovascular events and improve glycemic control in patients with type 2 diabetes. Janssen submitted the supplemental New Drug Application (sNDA) for INVOKANA to treat diabetic kidney disease in patients with type 2 diabetes to the US FDA, following the Phase 3 CREDENCE (canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) study.
The study was stopped early because it met the prespecified criteria for efficacy and demonstrated a 30% reduction in the risk of the primary composite endpoint, comprising end-stage kidney disease (ESKD), doubling of serum creatinine and renal or cardiovascular death. The FDA approved the new indication on 30 September 2019.
Vifor Pharma's dedicated nephrology salesforce in the US will promote INVOKANA to nephrologists. This salesforce will be complemented by Janssen's existing sales representatives and institutional representatives who have expertise in addressing internists, diabetologists, endocrinologists and cardiologists. The field medical teams of both companies will also be supporting this collaboration. Janssen will continue to lead marketing for INVOKANA.
Both parties have agreed not to disclose the financial terms of the agreement.
Stefan Schulze, COO and President of the Executive Committee at Vifor Pharma, said: "The addition of INVOKANA supports our ambition to become a global leader in nephrology and brings our nephrology portfolio up to twelve products."
Nearly half of all patients with type 2 diabetes can expect to develop diabetic kidney disease which causes a high risk of kidney failure and cardiovascular disease. Vifor says INVOKANA is the only diabetes medicine indicated to slow the progression of diabetic nephropathy (also known as DKD) and reduce the risk of hospitalisation for heart failure in patients with type 2 diabetes and diabetic kidney disease. When added to the current standard of care, INVOKANA represents gives greater treatment options for this large and under-served patient population.
