Regulatory Pathway for Achaogen Looks Better; Is It Aimed At Viable Commercial Market?

 
• By Cole Werble

With the FDA bottleneck for new anti-infectives showing signs of improvement, the next concern is whether providers will pay high premiums for new anti-infectives and the related challenge of finding the right patients to make high-cost treatments make sense.

As a strategy to increase its chances of FDA approval for the next-generation aminoglycoside anti-infective, plazomicin, Achaogen Inc. changed course after Phase II trials and narrowed the indication from a broad category of gram-negative bacterial infections to carbapenem-resistant Enterobacteriaceae.

As Achaogen explains in its recently filed prospectus for a $75 million initial public offering, “by focusing on the pathogen...

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