Amgen Drug Approved for Use Before Surgery

A drug manufactured by Amgen of Thousand Oaks to aid the production of red blood cells has received approval from the federal Food and Drug Administration to be used prior to surgery.

The drug, Procrit, is marketed by Ortho Biotech Inc., a unit of New Jersey-based Johnson & Johnson. Procrit is a genetically engineered version of a natural human hormone, erythropoietin, which stimulates bone marrow to produce red blood cells.

Ortho Biotech already sells Procrit for the treatment of anemia, in which defective red blood cells reduce the level of oxygen in the blood, often resulting in iron deficiency.

The FDA ruling allows the company to market the drug for use before most types of surgery to reduce the need for blood transfusions in anemic patients. The drug has not been approved for use before cardiac and vascular operations.

In one clinical study, only 16% of anemic patients treated with Procrit before surgery needed a blood transfusion, compared with 45% of those receiving a placebo.