Shots:

• The US FDA approval is based on APEKS-cUTI study assessing Fetroja vs imipenem/cilastatin (IPM/CS) in patients aged ≥18yrs. with cUTI who have limited or no alternative treatment options
• The pivotal APEKS-cUTI study resulted in higher response rate in microbiological eradication and clinical response at the test of cure (TOC)- met its 1EPs (72.6% vs 54.6%)- SAEs (4.7% vs 8.1%)
•  Fetroja is the first approved antibiotic that functions as a siderophore- act by penetrating the cell wall of gram-negative bacteria and overcome the resistance mechanism and binds to the ferric iron to gain additional cell entry. Fetroja has received FDA’s QIDP- BT and FT designation with its expected availability in the US in H1’20

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