By Frances Bishopp

Ortho Biotech Inc. has received approval from the FDA to market Procrit (Epoetin alpha), to reduce the need for blood transfusions in anemic patients scheduled to undergo elective non-cardiac, non-vascular surgery.

Procrit received its first indication in 1990 for treatment of anemia in HIV-infected, AZT-treated patients and for chronic renal failure in pre-dialysis. In April 1993, it was approved for an additional indication for the treatment of anemia associated with chemotherapy in non-myeloid cancers.

Amgen Inc., of Thousand Oaks. Calif., discovered the drug, called epoetin alfa, and currently manufactures it. Amgen markets the product under the name of Epogen, for chronic renal failure, and Ortho markets it as Procrit. Amgen licensed the product to Johnson & Johnson in 1989, under an agreement which included all indications in the U.S. other than kidney dialysis. Amgen also licensed to Ortho’s parent company, Johnson & Johnson, of New Brunswick, N.J., exclusive rights to all indications outside the U.S., except Japan and the People’s Republic of China.

Procrit stimulates the production of red blood cells prior to surgery to counter the effects of blood loss during some surgical situations, Craig Rothenberg, director of public affairs at Ortho Biotech Inc., of Raritan, N.J., told BioWorld Today. It is a genetically engineered version of the body’s natural hormone, erythropoietin, which is produced primarily in the kidneys and stimulates bone marrow to produce red blood cells.

This drug can be used as an alternative for a blood transfusion for anemic patients who, Rothenberg said, are scheduled for certain elective surgeries, such as hip or knee replacements.

Procrit will be put on the market immediately for the new indication, Rothenberg said. The average cost will be $1,500 for an average course of therapy, which would consist of four, once-weekly doses.

The drug would be administered three to four weeks before elective surgery, Rothenberg explained. “This drug essentially allows your own body to function as its own blood bank, to generate additional red blood cells in your body, to counter the effects of blood loss that you will experience during surgery,“ Rothenberg said. “As you lose blood during surgery, your red blood cell count is not being depleted because you have been proactively boosted prior to surgery. The result is you don’t become anemic.“

In a Phase III clinical study of 315 patients scheduled for elective orthopedic surgery, daily, pre-, peri-, and post-surgical administration of Procrit reduced the need for transfusion of donor blood, the company said. In a subgroup of mildly anemic patients, only 16 percent of Procrit-treated patients received a transfusion, compared to 45 percent of patients who received placebo. An additional Phase III study of 145 patients showed comparable efficacy to the daily schedule with a weekly dose administered prior to and on the day of surgery. All patients received anticoagulant therapy.