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A Phase 3, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Cefepime-AAI101 Compared to Piperacillin/Tazobactam in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis

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Trial Profile

A Phase 3, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Cefepime-AAI101 Compared to Piperacillin/Tazobactam in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Apr 2024

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At a glance

Most Recent Events

  • 15 Jun 2024 According to an ADVANZ PHARMA media release, the EC granted a marketing authorization for EXBLIFEP,for the treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis; hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP); and bacteraemia. EXBLIFEP will be marketed in the European Union, the United Kingdom, Switzerland, and Norway by ADVANZ PHARMA under a license and supply agreement closed with Allecra in 2022.
  • 27 Feb 2024 According to an Allecra Therapeutics media release, the company has received a five-year marketing exclusivity extension from the FDA as part of the Generating Antibiotic Incentives Now Act (GAIN Act).
  • 27 Feb 2024 According to an Allecra Therapeutics media release, the U.S. Food and Drug Administration (FDA) has approved EXBLIFEP (cefepime/enmetazobactam), as a treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, in patients 18 years and older.

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