Healthcare Industry News:  chronic kidney disease 

Biopharmaceuticals

 News Release - November 18, 2006

Majority of Anemic Chronic Kidney Disease Pre-Dialysis Patients Achieved Target Hemoglobin Range With PROCRIT(R) (Epoetin alfa) Therapy Initiated Every Two Weeks

SAN DIEGO, Nov. 18 (HSMN NewsFeed) -- Today, at the American Society of Nephrology's 39th Annual Meeting and Scientific Exposition, data was presented for the first time on the initiation of PROCRIT® (Epoetin alfa) therapy 20,000 Units once every two weeks in patients with anemia related to chronic kidney disease (CKD) who are not on dialysis. The FDA-approved initiation dose of PROCRIT for this patient population is 50-100 Units/kg three times per week.

In the study, the majority (>88 percent) of patients treated with PROCRIT 20,000 Units once every two weeks achieved a target hemoglobin (Hb) of between 11 and 12 grams per deciliter of blood (g/dL). The mean Hb reached the target range by week six and stayed in that range for the remainder of the 28-week study.

"These results suggest that anemic CKD patients not on dialysis may be administered PROCRIT less frequently at an initiation dose of 20,000 Units once every two weeks," explained the study's principal investigator, Robert Benz, MD, Chief, Division of Nephrology, Lankenau Hospital & Research Center in Wynnewood, PA.

Study Design

This prospective, open-label, single-arm, multi-center study investigated the effect of PROCRIT 20,000 Units administered once every two weeks on hemoglobin response. The primary endpoint of the study was the percentage of patients who achieved and maintained a hemoglobin level between 11 and 12 grams per deciliter of blood for at least two consecutive weeks by study week 28. The product labeling for PROCRIT recommends a target hemoglobin range between 10 and 12 grams per deciliter of blood.

The study included 67 patients with chronic kidney disease not on dialysis who had a baseline Hb level of <11g/dL. Patients were treated with a starting dose of PROCRIT 20,000 Units administered once every two weeks for up to 27 weeks, with final hemoglobin assessments performed at week 28. Dose adjustment was allowed after four weeks of treatment. Overall, PROCRIT increased Hb levels by 1 g/dL and 2 g/dL from the start of the trial in 91 percent and 78 percent of patients, respectively.

PROCRIT was well tolerated with most adverse events being mild to moderate and typical of patients with chronic kidney disease.

The study findings suggest the need for well-controlled clinical trials to evaluate the efficacy and safety of extended initiation dosing regimens of PROCRIT for the treatment of CKD-related anemia in patients not on dialysis. Ortho Biotech Products, L.P., markets of PROCRIT (Epoetin alfa). Dr. Benz received research support from Ortho Biotech Clinical Affairs, L.L.C.

About chronic kidney disease and Anemia

chronic kidney disease is a progressive condition in which the kidneys are unable to function effectively. As the kidneys' ability to function decreases, they become unable to help the body produce red blood cells, which contain oxygen-carrying hemoglobin, resulting in anemia. More than 20 million Americans have chronic kidney disease, and as many as two-thirds will develop anemia.

Anemia is a potentially debilitating condition that occurs when the body does not have enough red blood cells, which carry oxygen. Oxygen acts like fuel for the body, providing energy for muscles and organs to work. The kidneys produce erythropoietin, a hormone that tells the body to make red blood cells. As kidney function declines, the body may not make enough red blood cells, resulting in anemia. Symptoms of anemia include feeling tired or weak, shortness of breath, dizziness, decreased ability to concentrate and paleness.

About PROCRIT® (Epoetin alfa)

PROCRIT® (Epoetin alfa) is a prescription medication for the treatment of anemia in chronic kidney disease patients who are not on dialysis and is injected by doctors or nurses.

PROCRIT® is not for patients with uncontrolled high blood pressure. High blood pressure has been noted in patients treated with PROCRIT® and blood pressure should be monitored carefully. Drugs like PROCRIT® may increase the risk of blood clots and seizures.

Loss of response to PROCRIT® could be a sign of a very rare but serious condition. In studies, the most common side effects were high blood pressure, headache, joint pain and nausea.

Please visit www.PROCRIT.com for full prescribing information.

About Ortho Biotech Products, L.P.

Ortho Biotech Products, L.P. is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients' health. Located in Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recurrent ovarian cancer, rejection of transplanted organs and other serious illnesses. For more information, visit www.orthobiotech.com.


Source: Ortho Biotech

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