EXBLIFEP®


Associated tags: Biotechnology, Esbly, Safety, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Therapy, Cefepime, Supervisory board, Patient, Urinary tract infection, FDA, Cutis, Gram-negative bacteria, NDA, QIDP, Clinical Trials, Pharmaceutical, Health, Pharmaceutical industry

Allecra Therapeutics Announces U.S. FDA Approval for EXBLIFEP® for the Treatment of Complicated Urinary Tract Infections

Retrieved on: 
Tuesday, February 27, 2024
Health, FDA, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Therapy, ESBL, GAIN, Second Continental Congress, Urinary tract infection, Supervisory board, Pharmaceutics, Cutis, Partnership, Food, Pyelonephritis, Gram-negative bacteria, Patient, Congress, Medication, Pharmaceutical industry

Allecra Therapeutics (“Allecra”), a biopharmaceutical company developing novel therapies to combat antibiotic resistance, announced today that 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.

Key Points: 
  • Allecra Therapeutics (“Allecra”), a biopharmaceutical company developing novel therapies to combat antibiotic resistance, announced today that 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.
  • Allecra has also received a five-year marketing exclusivity extension from the FDA as part of the Generating Antibiotic Incentives Now Act (GAIN Act).
  • "Receiving FDA approval is a tremendous achievement for Allecra and a testament to the hard work and dedication of a small, yet highly focused team of individuals.
  • Enmetazobactam was first discovered by Orchid Pharma and all rights outside India were assigned to Allecra Therapeutics in 2013.

Allecra Therapeutics Submits New Drug Application to the U.S. FDA for EXBLIFEP® for the Treatment of Complicated Urinary Tract Infections

Retrieved on: 
Tuesday, June 27, 2023
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, QIDP, NDA, Gram-negative bacteria, Cutis, Urinary tract infection, Esbly, Patient, Supervisory board, Cefepime, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry

Allecra Therapeutics (“Allecra”) announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for cefepime/enmetazobactam, an antibiotic combination of the fourth generation cephalosporin cefepime with the proprietary beta lactamase inhibitor, enmetazobactam, for the treatment of complicated urinary tract infections (cUTIs).

Key Points: 
  • Allecra Therapeutics (“Allecra”) announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for cefepime/enmetazobactam, an antibiotic combination of the fourth generation cephalosporin cefepime with the proprietary beta lactamase inhibitor, enmetazobactam, for the treatment of complicated urinary tract infections (cUTIs).
  • Upon approval, the antibiotic combination will be marketed under the trademark name, EXBLIFEP®.
  • EXBLIFEP® has been designed to combat anti-microbial resistance in gram-negative bacteria, especially resistance mediated by Extended Spectrum Beta Lactamases (or ESBLs).
  • "This filing marks the culmination of a journey that began ten years ago with the formation of Allecra by a syndicate of European venture capital interests.