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Experimental Drug OKd for Use on AIDS Patients for First Time

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From a Times Staff Writer

Federal health officials Tuesday announced that they have approved the use of the experimental drug Trimetrexate to treat pneumocystis carinii pneumonia, a life-threatening infection that frequently afflicts AIDS patients.

Federal regulations that became effective last June permit drug developers to provide promising experimental drugs to patients under certain conditions before studies on the drug’s safety and efficacy have been completed.

The Food and Drug Administration and the National Institute of Allergy and Infectious Diseases said that Trimetrexate is the first AIDS-related drug to be granted such status under the regulations.

Although there are two other approved drugs to treat pneumocystis , many patients are allergic to them or experience other toxic reactions. Pneumocystis is a respiratory infection caused by a parasite that often strikes those whose immune systems are impaired, such as AIDS patients.

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Officials said the drug will be made available free to patients who qualify, with the infectious diseases institute--a branch of the National Institutes of Health--and the manufacturer, Warner-Lambert Co. of Morris Plains, N. J., handling distribution and bearing the cost.

“Today’s action reaffirms FDA’s commitment to broaden early patient access to promising experimental treatments for AIDS, AIDS-associated conditions and other life-threatening diseases,” FDA Commissioner Frank E. Young said in a statement.

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