Important note: Information in this article was accurate in 1986. The state of the art may have changed since the publication date.
The New York Times - December 23, 1986
Irvin Molotsky
The drug is clofazimine, which Ciba-Geigy will market under the brand name of Lamprene. Its stated purpose is to treat a form of leprosy that has become resistant to other drugs, and it has been used for that purpose for the last decade outside the United States.
Clofazimine was given an expedited approval by the agency as an "orphan" drug, so called because so few people would benefit from it in this country that a drug company was unlikely otherwise to go through the long and expensive review process.
There are 12 million cases of leprosy in the world outside the United States, the agency said, and today's approval makes the drug available for the 5,000 people in this country who suffer from leprosy, many of whom had been receiving the drug experimentally.
The drug is used to treat lepromatous leprosy, which the agency says is characterized by skin lesions and also can cause damage to the eyes, kidneys, testes and membranes of the mouth, nose and throat. Clofazimine, the agency determined, inhibits the growth of the bacteria that cause leprosy. How Approved Drug Works
Dr. Frank E. Young, Commissioner of Food and Drugs, says that clofazimine not only acts to clear the unsightly lesions of leprosy but it also suppresses infectiousness so that patients can circulate freely and function in society.
The F.D.A. says leprosy occurs in the United States in coastal areas of California, Florida, Hawaii, Puerto Rico, Texas and Louisiana. Outside the United States it occurs most commonly in Southeast Asia. It is sometimes brought into the United States by immigrants from that area.
Gloria Martini, a spokesman for Ciba-Geigy, said that clofazimine, in combination with other drugs, had been used to treat an infection related to acquired immune deficiency syndrome in 600 to 700 patients over the last two years as an experimental drug.
"The drug has no effect on the AIDS virus," Mrs. Martini stressed. "It is in no way a cure for AIDS." Use for AIDS-Related Infection
In those AIDS patients, she said, the drug has been used to treat an infection caused by the mycobacterium avium intracellulare.
Now that clofazimine has been approved for leprosy treatment, she said, it will be more easily available to doctors who have been using it for AIDS patients. Although the drug was not approved for AIDS cases, a physician could apply it to the related infection, as many have done.
Mrs. Martini said that 20 to 50 percent of AIDS sufferers come down with the bacterial infection, which she said spreads through the body like tuberculosis.
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