GAITHERSBURG, Md., Sept. 11 /PRNewswire/ -- As the Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) and Drug Safety and Risk Management Advisory Committee (DSRMAC) meet today to discuss questions related to erythropoiesis-stimulating agents (ESA's), Ortho Biotech reiterates its position on the following key issues that will be discussed:
* The studies being 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. When patients are treated according to the
label, PROCRIT(R) (Epoetin alfa) is a safe and effective therapeutic
option in the management of anemia in patients with chronic renal
* The weight of clinical evidence suggests that patients experience the
greatest benefit from a hemoglobin of between 10-12 g/dL, and that
patients who fall below a hemoglobin of 10 g/dL experience greater
morbidity and mortality, and are more likely to require a blood
* The company agrees that additional data are needed to determine how to
best identify and treat "ESA hyporesponders," or those patients who do
not respond adequately to ESA therapy.
PROCRIT represents a revolutionary treatment option in anemia management. ESAs, including PROCRIT, continue to be the only viable alternative to blood transfusions for the treatment of anemia in CRF patients. ESAs provide clear clinical benefit in CRF patients with regard to transfusion avoidance and improvements in physician-assessed and patient-reported outcomes. The benefits and risks of PROCRIT have been established in well-controlled clinical trials and observed in clinical experience over the past 18 years in four million patients worldwide across approved indications.
|SOURCE Ortho Biotech Products, L.P.|
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