The Food and Drug Administration yesterday approved a drug that combats the anemia that forces some people with AIDS or AIDS-related conditions to abandon life-prolonging AZT therapy.
The drug, Epoetin alfa, which is a genetically engineered form of the kidney protein erythropoietin, stimulates the production of red blood cells. Anemia is a lack of these cells.
Many AIDS patients taking AZT, the only anti-viral AIDS drug approved by the FDA, become so anemic that they need regular blood transfusions or are forced to give up the AZT therapy.
The FDA approved Epoetin alfa for use in patients with chronic kidney failure in June 1989.
At that time, while the drug's effects on AIDS and AIDS-related conditions were still being studied, the agency also expanded access to Epoetin alfa on an experimental basis for patients on AZT, also known as zidovudine.
The treatment has few adverse reactions. Most frequently reported are fever, headaches and fatigue, the FDA said.
Amgen Inc. of Thousand Oaks, Calif., will market the drug under an agreement with Ortho Pharmaceutical Corp. of Raritan, N.J. Amgen did much of the initial work in developing erythropoietin, while Ortho sponsored the clinical trials and expanded access of the drug for AIDS patients.
Amgen will market the drug under the trade name Epogen, and Ortho will market it under the name Procrit, the FDA said.
This was the seventh product approved by FDA for the treatment of AIDS or AIDS-related conditions, officials said.