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Achaogen Questioning Whether Others Will Pursue LPAD Pathway After Zemdri Misses Out

 
• By Michael Cipriano

Achaogen can take solace in US FDA's approval of the aminoglycoside antibacterial for the treatment of complicated urinary tract infections, but the limited use indication for bloodstream infections was rejected. 

Achaogen Inc. made headlines as the first drugmaker to file a new drug application (NDA) with the US FDA using the limited population antibiotic drug (LPAD) pathway, but the company now expresses concern that others may be deterred after the agency issued a complete response letter to the sought indication for Zemdri for bloodstream infections (BSI).

FDA unsurprisingly approved Zemdri (plazomicin), an aminoglycoside antibacterial, on June 25 for the treatment of complicated urinary tract infections (cUTI), including Pyelonephritis, in patients 18 and older who have limited or no alternative treatment options. In May, the Antimicrobial Drugs Advisory Committee unanimously endorsed the limited cUTI indication – which was not being pursued under LPAD

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