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October 16, 1991

First Infection-fighting Monoclonal Antibodies Scrutinized by FDA Advisory Committee Members

JAMA. 1991;266(15):2052. doi:10.1001/jama.1991.03470150020006

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AGENTS against some gram-negative infections are moving closer to receiving the Food and Drug Administration's (FDA's) green light.

If these agents are licensed, they will be the first monoclonal antibodies available for clinical use in the United States. Members of the FDA's Advisory Committee on Vaccines and Related Biological Products have heard from two manufacturers of these monoclonal antibodies that studies show a reduction in mortality and morbidity in patients with gram-negative sepsis.

While the committee has made no formal recommendations to the FDA commissioner for licensure of these products, the members do agree that one of them, Centoxin (HA-1A) (Centocor Inc, Malvern, Pa), could get the green light if the types of patients in which it is most likely to be useful can be identified with reasonable precision. The committee also says that if data analysis on the other product, E5 (Xoma Corp, Berkeley, Calif), shows similar efficacy, it,