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Target Locked: The first pathogen-targeted therapy for difficult-to-treat pneumonia

The US FDA has approved Entasis Therapeutics' XACDURO® for treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP and VABP) caused by difficult-to-treat Acinetobacter baumannii-calcoaceticus complex (A. baumannii).

A. baumannii are highly drug-resistant, Gram-negative, opportunistic bacteria primarily found in healthcare settings, where they cause severe pneumonia. These infections are associated with high morbidity and mortality and are difficult to treat, with limited treatment options available. Further, these bacteria have been recognized by the World Health Organization as critical pathogens posing the greatest risk to human health, underlining the need for new, effective antibacterial therapies.

XACDURO® is the first pathogen-targeted antimicrobial drug to be approved, meaning it only targets specific bacterial species. This is a novel approach to address the problem of antimicrobial drug resistance (AMR) among pathogenic bacteria, which has been aggravated by years of overprescribing broad-spectrum antimicrobial agents as empiric therapy for serious infections.

Approval of this novel treatment is backed by the Phase III ATTACK trial, where XACDURO® demonstrated statistical non-inferiority to comparator antibiotic colistin for 28-day all-cause mortality (death rate 19% vs. 32%) and led to lower nephrotoxicity (13% vs. 38%) in patients with carbapenem-resistant A. baumannii infections.

XACDURO® is expected to become available to patients later this year, and marks an important development in a field where antibiotic discovery has been regularly outpaced by rapidly evolving AMR.

Written by Zaraa Malvat


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