Antibiotics For Drug-Resistant Infections Hope To Skip Phase III Trials
PhRMA working group lays out proposal to allow approval of antibiotics for infections constituting an unmet medical need based on open-label studies and observational data.
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A limited population antibacterial drug pathway could reassure investors about the viability of antibiotics and help FDA avoid looking over its shoulder as it approves products based on limited data, though enactment is uncertain.
Achaogen has designed a registration program with a single Phase III study for its next-generation aminoglycoside, plazomicin, to treat serious infections due to carbapenem-resistant Enterobacteriaceae, in what could be an interesting test for potential modifications to the standard approval pathway.
Drug developers must show value, such as lower death rates, to justify high prices for antibiotics to treat drug resistant organisms, payers note during conference on the Limited Population Antibacterial Drug approval pathway.