Shionogi’s Fetroja (cefiderocol) Receives the US FDA’s Approval for the Treatment of Complicated Urinary Tract Infections

Shionogi’s Fetroja (cefiderocol) Receives the US FDA’s Approval for the Treatment of Complicated Urinary Tract Infections

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

Click here to­ read full press release/ article | Ref: Businesswire | Image: Fedaiisf