ST GALLEN, Switzerland–(BUSINESS WIRE)–Regulatory News:
Vifor Pharma today announced a commercial partnership with Janssen Pharmaceuticals Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, to jointly commercialize INVOKANA(R) (canagliflozin) in the US to treat DKD and reduce the risk of hospitalization for heart failure in patients with type 2 diabetes and diabetic kidney disease.
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. INVOKANA(R)is the only diabetes medicine indicated to slow the progression of diabetic nephropathy (also known as DKD) and reduce the risk of hospitalization for heart failure in patients with type 2 diabetes and diabetic kidney disease. When added to current standard of care, INVOKANA(R) represents an important advancement in treatment options for this large and under-served patient population.
INVOKANA(R) 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(R) to treat diabetic kidney disease in patients with type 2 diabetes to the U.S. Food and Drug Administration (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 pre specified criteria for efficacy and demonstrated a 30 percent 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(R) 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(R). 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 commented: “We are extremely pleased to have entered into this agreement with Janssen Pharmaceuticals, Inc. The addition of INVOKANA(R) supports our ambition to become a global leader in nephrology and brings our nephrology portfolio up to twelve products. We look forward to working closely with the Janssen team to maximize the potential of this important new treatment for people with type 2 diabetes who are also suffering from diabetic kidney disease.”
Vifor Pharma Group is a global pharmaceuticals company headquartered in Switzerland. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care); Relypsa; and OM Pharma. Vifor Pharma Group is listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).
For more information, please visit viforpharma.com.