AIDS Page: Progress Reports in the Battle against Acquired Immune Deficiency Syndrome
First Treatment Approved For Severe PCP
NeuTrexin (trimetrexate), the first drug specifically for severe Pneumocystis carinii pneumonia (PCP), a common life-threatening complication of AIDS, received FDA approval last Dec. 20. The drug has been available for five years under an FDA "Treatment IND."
NeuTrexin also is approved for moderate PCP. Though the drugs trimethoprimsulfamethoxazole, injectable pentamidine, and atovaquone are approved for milder forms of the disease, many PCP patients don't respond to, or cannot tolerate, these other drugs.
For protection against potential toxic effects, NeuTrexin must be administered simultaneously with leucovorin (folinic acid). Patients should be monitored carefully and must continue leucovorin therapy for 72 hours past the last dose of NeuTrexin.
In 1988, trimetrexate was the first AIDS-related therapy to be granted status under FDA's Treatment IND (investigational new drug) system. This program makes promising investigational drugs available to patients with certain serious or life-threatening diseases before clinical trials required for approval have been completed.
U.S. Bioscience Inc., of West Conshohocken, Pa., manufactures NeuTrexin.
New Uses for IGIV
Immune Globulin Intravenous (Human) (IGIV), first licensed by FDA in 1981 to treat immune deficiency syndromes, was licensed Dec. 27, 1993, for two new indications--to reduce bacterial infections and hospitalizations in HIV-infected children, and to protect against infections and graft-versus-host disease in bone marrow transplant recipients age 20 and older. …