PARIS, FRANCE and PRINCETON, NJ — March 12, 2002 — Sanofi-Synthélabo and Bristol-Myers Squibb Company announced today that the European Committee for Proprietary Medicinal Products (CPMP) has adopted a positive opinion recommending to grant a marketing authorization for irbesartan (Aprovel®, Karvea®) in the European Union for a new indication: treatment of diabetic renal disease in patients with hypertension and type 2 diabetes mellitus.
The European Union Commission usually grants approval four months after a CPMP positive opinion. Irbesartan, an angiotensin II receptor antagonist (AIIRA), already indicated for the treatment of hypertension, would be the first drug approved throughout the European Union for treating diabetic renal disease in people with high blood pressure and type 2 diabetes mellitus.
This additional indication is based on the PRIME (PRogram for Irbesartan Mortality and Morbidity Evaluations) program, consisting of two studies – IRMA-2 (IRbesartan MicroAlbuminuria Type 2 Diabetes Mellitus in Hypertensive Patients) and IDNT (Irbesartan Diabetic Nephropathy Trial). PRIME evaluated the effect of irbesartan on the protection of renal function in people with hypertension and type 2 diabetes in both early and late-stage renal disease.
The results of IRMA-2 were published in the September 20, 2001 issue of the New England Journal of Medicine. IRMA-2 showed irbesartan significantly reduces the risk of progression of renal disease in hypertensive patients with type 2 diabetes and microalbuminuria, a marker for early stage renal disease. In patients receiving 300 milligrams of irbesartan daily for about two years the relative risk reduction was 70 percent (p<0.001) for the development of overt type 2 diabetic nephropathy versus the control group (placebo plus other allowed medications to lower blood pressure).
"Data from the IRMA 2 study show clear evidence that irbesartan goes beyond effectively lowering blood pressure," said IRMA-2 principal investigator Professor Hans-Henrik Parving of the Steno Diabetes Center in Gentofe, Denmark. "Irbesartan also slows the development of diabetic renal disease, which is responsible for significant illness and death in millions of patients worldwide."
The results of IDNT were also published in the same issue of the New England Journal of Medicine. IDNT demonstrated that 300 milligrams of irbesartan administered for an average of 2.6 years slows the progression of diabetic nephropathy towards end-stage renal disease and its consequences (dialysis, transplantation, death) by 20 percent (p=0.02) versus the control group (placebo plus other allowed medications to lower blood pressure) and by 23 percent (p=0.006) versus amlodipine in hypertensive patients with overt type 2 diabetic nephropathy.