Important note: Information in this article was accurate in 1989. The state of the art may have changed since the publication date.
Food and Drug Administration, U.S. Department of Health and Human Services - June 26, 1989
Brad Stone -- (301) 443-3285
"The early release of this product," Secretary Sullivan said, "shows that HHS and its constituent FDA mean business when we say we want to speed the availability of AIDS-related drugs."
In the past, the severe anemia associated with AZT and AIDS has required repeated blood transfusions. In some cases, AZT has had to be discontinued.
The protein product, r-erythropoietin, is a form of a protein formed in the kidneys, erythropoietin, which stimulates the body's production of red blood cells. Scientists are able to make quantities of the protein for treatment through gene-splicing techniques.
Another erythropoietin product was approved by FDA on June 1, as a treatment for anemia associated with chronic kidney failure. However, today's action provides an experimental treatment regimen specifically designed to treat this AIDS-related anemia. Physicians participating in the r-erythropoietin protocol will receive the product at no cost.
FDA Commissioner Frank E. Young, M.D., Ph.D., said, "This new biotech product should improve the quality of life for those whose lives depend upon zidovudine. Its premarket release -- the fourth for AIDS-related products -- reaffirms HHS' and FDA's commitment to providing people with life-threatening and serious diseases the earliest possible access to promising treatments." FDA is a part of the Public Health Service within HHS.
In controlled clinical studies involving more than 100 AIDS patients who had experienced severe anemia from zidovudine, r-erythropoietin appeared to restimulate the production of red blood cells and reduce or eliminate the need for transfusions.
The data from this study served as the basis for granting today's "treatment IND" status. (IND stands for investigational new drug.) This status allows patients suffering from serious or life-threatening conditions to get pre-approval access to experimental drugs that have shown significant promise.
Under this treatment IND protocol, AZT patients and other AIDS patients who have experienced severe anemia will be eligible to receive r-erythropoietin treatment. The product will initially be in limited supply but its availability will be expanded during the next several weeks.
Ortho Pharmaceutical Corp. of Raritan, N.J., will sponsor the treatment IND protocol. The company has also filed a product license application for r-erythropoietin which FDA is currently reviewing.
Physicians interested in the details of this treatment IND protocol can contact an Ortho hotline at (800) 243-7739.
890626
FD890602
SOURCE: Food and Drug Administration (FDA).
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, the Elton John AIDS Foundation, National Library of Medicine, and donations from users like you.
Always watch for outdated information. This article first appeared in 1989. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 1989. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .