Vifor Pharma, headquartered in Switzerland, announced it has partnered with Janssen Pharmaceuticals to co-market Invokana (canagliflozin) in the United States.
The drug is intended to treat diabetic kidney disease (DKD) and to reduce the risk of hospitalisation due to heart failure secondary to type 2 Diabetes.
For this patient population, Vifor Pharma said the combination of the medication with the existing standard of care offers a new therapy option.
Nearly 50% of patients with type 2 diabetes are at high risk to develop, kidney failure, DKD and cardiovascular Insufficiency associated with type2 Diabetes.
Invokana intended to treat diabetic kidney disease (DKD)
Invokana is a diabetes medicine intended to slow the progression of DKD or diabetic nephropathy and also to minimise the risk of hospitalisation in this patient population for heart failure.
The medicine is already being marketed in the United States to mitigate the risk of significant cardiovascular events and to boost glycaemic regulation in patients with type 2 diabetes.
Janssen applied for supplementary new drug approval (sNDA). to the US Food and Drug Administration (FDA), to treat DKD in people with type 2 diabetes.
The sNDA supports data from the clinical trial Phase III CREDENCE, where the drug resulted in a 30 percent decrease the risk of end-stage kidney disease (ESKD) primary composite endpoint, doubling serum creatinine and renal or cardiovascular death.
The application was approved by the FDA in September 2019. The approval was based on the landmark Phase 3 CREDENCE renal outcomes study, the only completed renal outcomes study of a diabetes medicine as the Janssen Pharmaceutical Companies of Johnson & Johnson announced at the time.
Vifor Pharma’s US nephrology salesforce will market Invokana to nephrologists as part of the commercial collaboration.
Vifor Pharma will be supported by existing sales and institutional representatives with expertise in addressing diabetologists, cardiologists, endocrinologists and internists. Partners ‘ field medical teams will also be supporting the coalition.
Vifor Pharma COO and Chairman of the Executive Committee Stefan Schulze said:
Invokana’s addition supports our goal to become a global leader in nephrology and brings up to twelve drugs to our nephrology portfolio. We look forward to working closely with the Janssen team to optimise the potential of this exciting new treatment for people with DKD secondary to type 2 diabetes.
Either company is yet to publish the financial details of the alliance.
November 04, 2019 ST GALLEN, Switzerland-(BUSINESS WIRE)–Regulatory News: Vifor Pharma Enters Into Commercial Collaboration in the US with Janssen
September 30, 2019 RARITAN, N.J. U.S. -(JNJ) FDA Approves INVOKANA® (canagliflozin) to Treat Diabetic Kidney Disease (DKD) and Reduce the Risk of Hospitalization for Heart Failure in Patients with Type 2 Diabetes (T2D) and DKD