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"ESA use within the label has not been associated with increased risk ofmortality or disease progression," said Craig Tendler, M.D., Vice President,Medical Affairs, Oncology/Nephrology, Ortho Biotech Products, L.P. "OrthoBiotech looks forward to Thursday's ODAC meeting, at which we hope thatresponsible recommendations will be made based on the totality of availableevidence, including a substantial body of scientific data submitted to the FDAover the past several months."
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The company has provided to the FDA all available clinical data fromrelevant, randomized controlled trials of ESAs to treat CIA. "The known risksof ESA use are prominently displayed in the current product labeling, and wewill continue to support direction to healthcare professionals to use thelowest dose of ESAs that will gradually increase the hemoglobin concentrationto a level that will avoid the need for blood transfusion," Dr. Tendler said.
In addition to working closely with the FDA, Ortho Biotech, along withindependent investigators and other ESA manufacturers, has provided data tothe independent Cochrane Collaboration to facilitate a patient-level analysisof all data from appropriately designed and conducted controlled clinicalstudies. This project will create a database of more than 15,000 patients,making it the largest combined analysis of ESA safety data ever undertaken.The company also has proposed unrestricted funding to support independentresearch through the National Cancer Institute to evaluate potentialmechanisms that may mediate adverse outcomes when ESAs are used to treat CIA.
About PROCRIT (Epoetin alfa)
PROCRIT is used for the treatment of anemia in patients with most types ofcancer receiving chemotherapy, with chronic renal failure who are on dialysisand those who are not on dialysis, who are being treated with zidovudine forHIV infection, and to reduce the need for transfusion in anemic patients whoare scheduled for elective noncardiac, nonvascular surgery. Depending on thecountry in which Epoetin alfa is marketed, these indications may differ.
Important U.S. Safety Information for PROCRIT
Boxed WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR andTHROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION
Renal failure: Patients experienced greater risks for death and seriouscardiovascular events when administered erythropoiesis-stimulating agents(ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve andmaintain hemoglobin levels within the range of 10 to 12 g/dL.
Perisurgery: PROCRIT(R) increased the rate of deep venous thromboses inpatients not receiving prophylactic anticoagulation. Consider deep venousthrombosis prophylaxis.
Contraindications
PROCRIT is contraindicated in patients with uncontrolled hypertension orwith known hypersensitivity to albumin (human) or mammalian cell-derivedproducts.
Please visit www.procrit.com for the full Prescribing Information,including the Boxed WARNINGS.
About Ortho Biotech Products, L.P.
Ortho Biotech Products, L.P. is a leading biopharmaceutical companydevoted to helping improve the lives of patients with cancer and with anemiadue to multiple causes, including chronic kidney disease. Since it wasfounded in 1990, Ortho Biotech and its worl
