FDA Speeds Approval of 2 Key Drugs in AIDS Battle

The Food and Drug Administration, continuing to step up efforts to give AIDS patients quicker access to drugs, today took action on treatments for two of the most serious complications of AIDS.

FDA Commissioner Frank Young announced official approval of ganciclovir, a drug that combats an eye infection that strikes about one in four AIDS patients and can eventually lead to blindness.

In addition, Young said the government is permitting wider use of an experimental drug to treat the severe anemia that afflicts many patients with acquired immune deficiency syndrome, particularly those receiving the anti-viral drug AZT.

“These therapies, together with the approval of aerosolized pentamidine (which fights AIDS-related pneumonia) earlier this month, indicate that the face of AIDS is changing,” Young said. “Medicine can now extend and improve the quality of life of people with AIDS, even though there is still no definitive cure.”

Bill Case, executive director of People With AIDS in New York City, called the latest FDA action a “very positive stand,” but added, “We would like to see things go even faster.” About 100 AIDS-related drugs are currently in FDA-supervised tests.

About half of the 20,000 AIDS patients taking AZT--the only government-approved drug to directly attack the AIDS virus--suffer from severe anemia caused by the life-extending but toxic drug, Young said. Such anemia currently is treated by transfusions of oxygen-carrying red blood cells, but in severe cases AZT treatment may have to be stopped.

Recent studies of about 100 AIDS patients with AZT-linked anemia showed another drug, recombinant erythropoietin or EPO, reduced or eliminated the need for transfusions.

The FDA earlier this month approved EPO for use in kidney patients with severe anemia, but the genetically engineered drug is not officially sanctioned for use in AIDS patients and is undergoing tests for that purpose.

The decision to allow distribution of EPO before approval should give AIDS patients better access to the drug, as well as provide doctors with better guidelines on how to use EPO in such cases, Young said.

Young cautioned more studies of ganciclovir are needed. The FDA commissioner noted ganciclovir, made by Syntex Corp., of Palo Alto, Calif., only delays and does not prevent the sight-destroying progression of cytomegalovirus retinitis infection.