Mixed messages from the US Food and Drug and Administration’s advisory panel unsettled Achaogen (Nasdaq: AKAO) shareholders this week, with the vote falling in favor of approval of the antibiotic plazomicin for complex urinary tract infections (cUTI) but not for its use against bloodstream infections.
Plazomicin is an aminoglycoside that was developed to treat serious bacterial infections due to multidrug resistant gram-negative bacteria.
The panel voted unanimously in favor of approval for the candidate for cUTIs, but 11-4 against for bloodstream infections. While the FDA is not bound by the panel’s view, it usually follows its advice.
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