Cutis

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.

IDWeek 2023: Shionogi Presents New Real-World Evidence Demonstrating Effectiveness of Earlier Treatment with Fetroja® (cefiderocol) in Appropriate Patients

Retrieved on: 
Wednesday, October 11, 2023
Hospitals, Pharmaceutical, Health, Clinical Trials, Infection, Klebsiella pneumoniae, FRCP, Senior, COVID-19, Cutis, Doctor of Philosophy, Drug, Research, Acinetobacter baumannii, Albany College of Pharmacy and Health Sciences, Death, Mortality, Safety, Outline of health sciences, Pseudomonas aeruginosa, Diabetes, Associate professor, Heart, Head, Kidney, RWE, RCT, Stenotrophomonas maltophilia, Blood, Urinary tract infection, Doctor of Pharmacy, Patient, AMR, Pharmaceutical industry, Vaccine, Nursing, Cefiderocol, MD, Klebsiella, Bachelor of Medicine, Bachelor of Surgery, Shionogi

“Seriously ill patients are often not represented in randomized clinical trials due to the difficulty with interpreting outcomes in such confounding situations.

Key Points: 
  • “Seriously ill patients are often not represented in randomized clinical trials due to the difficulty with interpreting outcomes in such confounding situations.
  • The patients included in this analysis were generally seriously ill and half (53.1%) were in the intensive care unit.
  • The most common pathogens identified among patients were Pseudomonas aeruginosa (48.7%), Acinetobacter baumannii (23.6%), Klebsiella pneumoniae (14.2%), and Stenotrophomonas maltophilia (13.1%).
  • Fetroja was used as monotherapy in 33% of patients (n=92), though most patients (92%, n=253) had received other antibiotics prior to Fetroja.

Venatorx Pharmaceuticals Announces FDA Acceptance and Priority Review of New Drug Application for Cefepime-Taniborbactam to Treat Complicated Urinary Tract Infections (cUTI), including Pyelonephritis, in Adults

Retrieved on: 
Tuesday, August 15, 2023
Health, FDA, Infectious Diseases, Clinical Trials, Research, Science, Pharmaceutical, Priority review, Senior, Pyelonephritis, Medicine, Infection, New Drug Application, NDA, Cutis verticis gyrata, Prescription Drug User Fee Act, Cutis, Medication, Urinary tract infection, Genetically modified bacteria, Patient, Test, PDUFA, Viral, Meropenem, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry

The FDA previously granted Qualified Infectious Disease Product and Fast Track designations to cefepime-taniborbactam.

Key Points: 
  • The FDA previously granted Qualified Infectious Disease Product and Fast Track designations to cefepime-taniborbactam.
  • The FDA has granted Priority Review of the NDA with a Prescription Drug User Fee Act (PDUFA) target action date of February 22, 2024.
  • “The NDA acceptance represents the culmination of unwavering dedication, scientific excellence, and the collaborative efforts of our talented team, partners, and clinical investigators,” said Christopher J. Burns, Ph.D., Chief Executive Officer of Venatorx.
  • “Patients with cUTIs, including pyelonephritis, and their healthcare providers should have a new treatment option when confronted with infections due to these antibacterial resistant infections.”

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.

Pathnostics Announces Publication in Research and Reports in Urology of its Interim Analysis for a Prospective Observational Study Evaluating Guidance® UTI in Patients with Complicated Urinary Tract Infections

Retrieved on: 
Tuesday, May 2, 2023
Infection, Pyelonephritis, Doctor of Philosophy, Urinary tract infection, UTI, Cutis marmorata telangiectatica congenita, Hope, Risk, Cutis, Patient, Health, Recurrence, PCR, Pharmaceutical industry, MD, Urology

IRVINE, Calif., May 2, 2023 /PRNewswire/ -- Pathnostics , a leading precision diagnostic testing and development company, today announced publication of data from the Company's interim analysis for a prospective observational study evaluating Guidance® UTI in patients with complicated urinary tract infections (cUTIs) in the peer-reviewed journal Research and Reports in Urology .

Key Points: 
  • IRVINE, Calif., May 2, 2023 /PRNewswire/ -- Pathnostics , a leading precision diagnostic testing and development company, today announced publication of data from the Company's interim analysis for a prospective observational study evaluating Guidance® UTI in patients with complicated urinary tract infections (cUTIs) in the peer-reviewed journal Research and Reports in Urology .
  • 3,4,5
    "This peer-reviewed publication of data is an important validation of the precision diagnostics delivered through Guidance UTI to improve the quality of patient care.
  • The prospective study compared patients who were treated with antibiotics after being diagnosed through Guidance UTI testing versus patients who had symptoms but were not treated using antibiotics.
  • Higher percentages of treated patients than of untreated patients achieved clinical cure for polymicrobial infections on day 14 (58.7% vs. 36.4%, p=0.049).

ECCMID 2023: Shionogi Announces Real-World Evidence Demonstrating the Efficacy of Fetcroja® / Fetroja® (cefiderocol) Against Some of the Most Difficult-to-Treat Gram-Negative Bacterial Pathogens

Retrieved on: 
Monday, April 17, 2023
Biotechnology, Infectious Diseases, Health, Pharmaceutical, Clinical Trials, Interim, University, Head, Consultant, Infection, AMR, Fungal infection, Cutis, Acinetobacter baumannii, Urinary tract infection, Pseudomonas aeruginosa, Congress, Death, Cefiderocol, ECCMID, Patient, European, Mortality, Intensive care medicine, Gram-negative bacteria, Salvage therapy, Pharmaceutical industry, Vaccine, EU, Shionogi

These were generally seriously ill patients, many requiring mechanical ventilation and/or vasopressor support.

Key Points: 
  • These were generally seriously ill patients, many requiring mechanical ventilation and/or vasopressor support.
  • Cefiderocol was initiated for a documented pathogen in the majority of cases (77%), and as monotherapy in 57% of patients.
  • Cefiderocol achieved clinical cure in 60% of patients, and 76% of patients were alive within 30-days of starting treatment.
  • Cefiderocol was targeted as first treatment or as salvage therapy in 93% of patients, and as monotherapy in 41% of patients.

ECCMID 2023: Shionogi Announces Real-World Evidence Demonstrating the Efficacy of Fetcroja® (cefiderocol) Against Some of the Most Difficult-to-Treat Gram-Negative Bacterial Pathogens

Retrieved on: 
Monday, April 17, 2023
Health, Infectious Diseases, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Interim, University, Head, Consultant, Infection, AMR, Fungal infection, Cutis, Acinetobacter baumannii, Urinary tract infection, Pseudomonas aeruginosa, Congress, Death, Cefiderocol, ECCMID, Patient, European, Mortality, Intensive care medicine, Gram-negative bacteria, Salvage therapy, Pharmaceutical industry, Vaccine, EU, Shionogi

These were generally seriously ill patients, many requiring mechanical ventilation and/or vasopressor support.

Key Points: 
  • These were generally seriously ill patients, many requiring mechanical ventilation and/or vasopressor support.
  • Cefiderocol was initiated for a documented pathogen in the majority of cases (77%) and as monotherapy in 57% of patients.
  • Cefiderocol achieved clinical cure in 60% of patients, and 76% of patients were alive within 30-days of starting treatment.
  • Cefiderocol was targeted as first treatment or as salvage therapy in 93% of patients, and as monotherapy in 41% of patients.

Allecra Therapeutics Publishes Final Phase 3 ALLIUM Data in JAMA: Cefepime/Enmetazobactam Met Criteria for Superiority

Retrieved on: 
Wednesday, October 5, 2022
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, European Medicines Agency, Robert Wood Johnson Medical School, Union, LinkedIn, Urinary tract infection, Therapy, Infection, Review, EMA, Bacterial pneumonia, Carbapenem, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Investor, Standard of care, MPH, Division, Piperacillin/tazobactam, UTI, Partnership, Food, Company, Marketing, MD, Esbly, Pyelonephritis, Adult, Cutis, Cutis marmorata telangiectatica congenita, American Medical Association, Journal, United Kingdom, Rutgers University, FDA, Tazobactam, Data analysis, ESBL, Pharmaceutical industry, EU

The publication represents the first full analysis of the completed Phase 3 program, which showed that cefepime/enmetazobactam met criteria for non-inferiority and superiority compared to piperacillin/tazobactam in the primary outcome of clinical cure and microbiological eradication.

Key Points: 
  • The publication represents the first full analysis of the completed Phase 3 program, which showed that cefepime/enmetazobactam met criteria for non-inferiority and superiority compared to piperacillin/tazobactam in the primary outcome of clinical cure and microbiological eradication.
  • Cefepime/enmetazobactam is a novel -lactam/-lactamase inhibitor combination for the treatment of resistant gram-negative infections mediated by Extended Spectrum Beta-Lactamases (ESBLs).
  • Based on the positive data readout, Allecra expects to submit for marketing approval in the U.S. and EU.
  • Allecra Therapeutics, founded in 2013, is a private, clinical-stage biopharmaceutical company developing novel therapies to combat antibiotic resistance by overcoming emergent resistance mechanisms.

Pathnostics to Present New Real-World Method to Identify and Evaluate Cost Outcomes of a Novel, Uncoded UTI Diagnostic at the International Society for Pharmacoeconomics and Outcomes Research 2022 Annual Meeting

Retrieved on: 
Monday, May 16, 2022
Pharmacoeconomics, Risk, International Society, Urinary tract infection, Nasdaq-100, National Harbor, Maryland, Cutis, Infection, Multimedia, Patient, Poster, View, Solution, Microbiology, Health, Nature Reviews Microbiology, UTI, Health care, Epidemiology, Medicare, International Society for Pharmacoeconomics and Outcomes Research, Conference, PCR, SUC, Therapy, MRU, Medical imaging, MD

IRVINE, Calif., May 16, 2022 /PRNewswire/ -- Pathnostics, a leading precision diagnostic testing and development company, today announced that it will present a new Medicare-claims-based method to identify an uncoded novel diagnostic (NDx), Guidance® UTI, and an analysis that found significantly lower costs as compared to standard urine culture (SUC) in patients with complicated urinary tract infections (cUTIs). The methodology and key findings will be presented at the 2022 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Meeting, taking place from May 15-18, in National Harbor, MD.

Key Points: 
  • The methodology and key findings will be presented at the 2022 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Meeting, taking place from May 15-18, in National Harbor, MD.
  • Complicated urinary tract infections, which must be treated early and accurately to reduce the risk of poor outcomes, are a significant burden on individual health and healthcare resources.
  • Annually, UTIs contribute to 10.5 million office visits and carry a cost of approximately $3.5 billioni.
  • Details of the poster presentation are as follows:
    The abstract and poster are now available on the ISPOR 2022 Conference website.

New Real-World Evidence Shows Improvements in Outcomes and Reduction in Healthcare Costs with Guidance® UTI Precision Diagnostic Test Compared to Standard Urine Culture in Patients with Complicated Urinary Tract Infections

Retrieved on: 
Saturday, May 14, 2022
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IRVINE, Calif., May 14, 2022 /PRNewswire/ -- Real-world evidence from a Medicare database analysis presented today at the 2022 American Urology Association (AUA) Meeting shows that Guidance UTI testing is associated with reductions in critical adverse outcomes, healthcare resource utilization and costs for complicated urinary tract infections (cUTIs) compared to standard urine culture (SUC). The comparative analysis was designed to examine outcomes of one year of cUTI treatment guided by either Guidance UTI or SUC.

Key Points: 
  • The findings reinforce the real-world benefits of Guidance UTI's increased sensitivity, reduced time to results, and P-AST results to patients, providers, and the healthcare system."
  • UTI-related clinical, healthcare use and costs outcomes were then tracked for one year.
  • Guidance UTI testing was associated with 44% lower total costs and 77% lower clinically-advanced costs* compared to SUC, and cUTIs in the Guidance UTI cohort were likelier to be managed successfully as outpatients.
  • The rate of outpatient emergency visits was 13% lower and inpatient admissions were 67% lower when using Guidance UTI compared to SUC.