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FDA Panel Offers Specifics For Revised CAP Trial Guidance, No Big Changes

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Advisory committee proposes a 10% non-inferiority margin for community-acquired pneumonia drugs. The Anti- Infective Drugs panel agreed that it is possible to establish a treatment effect for comparator agents based on incomplete data from original placebocontrolled CAP trials of the early 1900s. However, the group was divided over whether there is a basis for evaluating endpoints other than mortality. There was consensus that placebo-controlled trials are inappropriate for any severity of CAP

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