Irbesartan, First Drug Approved throughout European Union for Patients with High Blood Pressure and Type 2 Diabetic Renal Disease PARIS, FRANCE — June 27, 2002 —
Bristol-Myers Squibb Company and Sanofi-Synthelabo yesterday announced that the European Commission has approved irbesartan (Irban) in the European Union for a new indication: the treatment of renal disease in people with hypertension and type 2 diabetes mellitus (as part of a antihypertensive drug regimen).
Irbesartan is the first blood pressure lowering drug approved across the European Union for treatment of both early and late stage diabetic renal disease in hypertensive type 2 diabetic patients. Irbesartan, an angiotensin II receptor antagonist (AIIRA) is already indicated for the treatment of essential hypertension.
“Today, we enter a new era in the treatment of diabetic kidney disease,” said Dr. Luis Ruilope, Professor of Medicine and Chief of the Hypertension Unit at Hospital 12 de Octubre, Madrid, Spain, a European Clinical Coordinator from the IDNT study.
“For the first time, we now have an approved treatment – irbesartan – that can slow the progression of kidney disease in people with high blood pressure and type 2 diabetes. Now we have a treatment that is not only an excellent blood pressure lowering agent but that also has the ability to protect the kidneys from damage, above and beyond its effect on blood pressure lowering.”
This new 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) in people with hypertension and type 2 diabetes. PRIME is the first clinical program to evaluate hypertensive type 2 diabetic patients across the broad spectrum of early (IRMA-2) and late stage (IDNT) kidney disease.
“Results from the PRIME study demonstrate that treating type 2 diabetes as early as possible can make a dramatic difference in the resulting illness and death caused from this disease in millions of patients worldwide,” said IRMA-2 Principal Investigator, Professor Hans-Henrik Parving, Steno Diabetes Centre, Gentofe, Denmark. He continued, “Physicians now have a valuable new tool in irbesartan which slows the progression of kidney disease, and delays or prevents the need for dialysis or a kidney transplant.”
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