The US Food and Drug Administration accepted for filing King Pharmaceuticals' supplemental new drug application seeking a new indication for Altace (ramipril). King is seeking approval of an indication for Altace as initial therapy in a multi-drug regimen to delay the progression of chronic kidney disease in hypertensive patients with non-diabetic kidney disease.
King is seeking an expansion of the label for this indication based on a compilation of data from two, randomized clinical trials: the AASK (African American Study of Kidney Disease and Hypertension) trial1 and the REIN (Ramipril Efficacy In Nephropathy) trial. The AASK trial, a randomized US clinical study, evaluated the efficacy of Altace and two other treatment
regimens in 1094 African Americans with hypertension, using clinical outcomes of changes in glomerular filtration rate, slowing the progression of end-stage renal disease, and mortality.
Charles L. Pamplin, Vice President, Medical Affairs of King, stated, "Reducing the progression of chronic kidney disease will not only improve the quality of life for many patients suffering from chronic kidney disease and end-stage renal disease, but will also reduce the significant healthcare burden associated with these ailments."
Altace is marketed by Monarch Pharmaceuticals, Inc., a wholly owned subsidiary of King Pharmaceuticals, and Wyeth Pharmaceuticals in the United States and Puerto Rico pursuant to a co-promotion agreement.