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Targeted Antibiotics Could Get Limited Data Approval Option From FDA

 
• By Cathy Dombrowski

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.

FDA is open to accepting less data for antibiotics than that provided by two Phase III trials if the drugs target infections caused by drug-resistant bacteria for which there are few therapeutic options.

A “more limited development program holds promise as a pathway for the development of new drugs for those patients for whom there’s a critical need for new antibacterial drugs” and...

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More from North America

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