GAITHERSBURG, Md., Sept. 11 /PRNewswire/ -- Ortho Biotech is pleased with recommendations of the Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) and Drug Safety and Risk Management Advisory Committee (DSRMAC) resulting from the Committees' evaluation of the use of erythropoiesis-stimulating agents (ESAs) for patients with chronic renal failure (CRF).
"Ortho Biotech supports the Committees' recommendation not to change the target hemoglobin, supporting the company's position that PROCRIT(R) (Epoetin alfa) is a safe and effective therapeutic option in the management of anemia in patients with chronic renal failure (CRF) when patients are treated according to the label," said Marsha Wolfson, M.D., Senior Director, Nephrology Clinical Affairs, Ortho Biotech. The studies examined by the FDA Advisory Committees evaluated hemoglobin targets above 13 grams per deciliter of blood (g/dL). In March 2007, label guidance for all ESAs was revised to reflect a maximum hemoglobin of 12 g/dL.
"We are also pleased that the Committees agreed that ESA dosages used to achieve the hemoglobin levels in the Normal Hematocrit and CHOIR studies are sufficient to form the basis for ESA dosage recommendations," Dr. Wolfson commented. "Furthermore, we support the Committee's recommendation on additional label guidance and further analyses toward identifying and appropriately treating patients who exhibit a poor response to ESAs."
At the meeting, the nation's leading kidney physicians and patient
organizations reaffirmed during the public comment session that ESAs remain
the only viable alternative to blood transfusions for the treatment of
anemia in CRF patients. Nearly two decades of clinical evidence, and
physician and patient experience reinforce that ESAs provide clear clinical
benefit in CRF patients, and we are pleased that the Committees
acknowledged the medications' role avoiding transfusion and improving
|SOURCE Ortho Biotech Products, L.P.|
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