Sponsors Seek One-Trial Approval Of Antibiotics For Drug-Resistant Bugs
Antibiotic developers are urging FDA to approve medicines to treat drug-resistant microbes on the basis of a single trial, with other supportive clinical and preclinical data to be used as substantiating evidence.
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FDA public workshop will consider the design of clinical studies testing antibacterial drugs to treat lung damage caused by recurrent infections.
The agency would like to have a “special medical use” category for drugs, such as antibiotics for bacteria resistant to current therapies, that could be approved based on small trials and whose labeling says they should not be prescribed off-label.
A non-inferiority trial with a pre-specified non-inferiority margin is the most likely design for investigational antibacterial drugs targeted at cUTI, according to FDA draft guidance. Primary efficacy endpoint needs to include resolution of symptoms, on top of microbiological success.