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Source: http://www.cidrap.umn.edu/news-persp...an-oct-17-2019
Stewardship / Resistance Scan for Oct 17, 2019
Panel approves new antibiotic; Improper antibiotic prescribing in Japan
Filed Under:
Antimicrobial Stewardship
FDA advisors approve new antibiotic cefiderocol for complicated UTI
In a 14-2 vote, the US Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee yesterday recommended that the new antibiotic cefiderocol, made by Shionogi & Co, Ltd, of Japan, be approved for complicated urinary tract infection (cUTI), including pyelonephritis, caused by gram-negative bacteria in patients who have limited or no alternative treatment options available, the company said in a news release.
Committee members weighed an imbalance in deaths in the CREDIBLE-CR trial, a phase 3 study that compared cefiderocol against the best available therapy in patients with cUTIs, severe pneumonia, and bloodstream infections or sepsis caused by carbapenem-resistant infections. Death rates in the cefiderocol group outpaced those in the other group 15.8% to 8.2%, but the data also showed an imbalance in deaths caused by underlying comorbidities, 9.9% to 4.1%. The experts also analyzed data on a separate phase 3 trial and a phase 2 trial.
Isao Teshirogi, PhD, Shionogi president and CEO, said in the release, "Patients with cUTIs caused by Gram-negative pathogens continue to face a serious challenge with high morbidity and mortality rates. If approved, we believe cefiderocol could help address a significant unmet need in an area with limited treatment options to fight these life-threatening infections."
Cefiderocol is a siderophore cephalosporin with a novel method of penetrating the tough outer membrane of gram-negative bacteria, including carbapenem-resistant pathogens. It is eligible to be fast-tracked for FDA approval.
The FDA is not bound by the committee's vote but typically follows its recommendations.
Some committee member said any FDA approval should carry with it a boxed warning on the drug's label, the strongest the agency uses, according to a story yesterday by MedPage Today. The two committee members who voted no—Peter Weina, MD, PhD, of Defense Health Headquarters in Falls Church, Virginia and Susanne May, PhD, with the University of Washington in Seattle expressed safety concerns and said more research is needed.
Oct 16 Shionogi news release
Oct 16 MedPage Today story
Antibiotic prescribing high for non-bacterial respiratory illness in Japan
About one third of Japanese patients with non-bacterial acute respiratory tract infections (NB-ARTIs) are inappropriately prescribed antibiotics, according to a new study in PLOS One.
The observational study used longitudinal claims data between April 2012 and June 2017. Though the monthly antibiotic prescribing rate per 100 NB-ARTI consultations decreased by 19.2% during the study period, the authors said the average monthly rate was still 31.65 prescriptions per 100 NB-ARTI consultations.
"Approximately 89% of antibiotics prescribed for NB-ARTI during the study period were broad-spectrum antibiotics, specifically third-generation cephalosporins (40.1%), macrolides (34.1%), and fluoroquinolones (14.4%)," the authors said. Adults ages 19 to 29 were the most likely to be prescribed antibiotics for NB-ARTI.
The diagnoses that yielded the highest antibiotic prescriptions were acute bronchitis and acute tonsillitis.
"Identified factors associated with inappropriate antibiotic prescription in our study, such as patients of working-age, clinic types, and specialties of clinics may be associated with patient expectation for antibiotics, time pressure, and diagnostic uncertainty, respectively," the authors concluded.
Oct 16 PLOS One study
Stewardship / Resistance Scan for Oct 17, 2019
Panel approves new antibiotic; Improper antibiotic prescribing in Japan
Filed Under:
Antimicrobial Stewardship
FDA advisors approve new antibiotic cefiderocol for complicated UTI
In a 14-2 vote, the US Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee yesterday recommended that the new antibiotic cefiderocol, made by Shionogi & Co, Ltd, of Japan, be approved for complicated urinary tract infection (cUTI), including pyelonephritis, caused by gram-negative bacteria in patients who have limited or no alternative treatment options available, the company said in a news release.
Committee members weighed an imbalance in deaths in the CREDIBLE-CR trial, a phase 3 study that compared cefiderocol against the best available therapy in patients with cUTIs, severe pneumonia, and bloodstream infections or sepsis caused by carbapenem-resistant infections. Death rates in the cefiderocol group outpaced those in the other group 15.8% to 8.2%, but the data also showed an imbalance in deaths caused by underlying comorbidities, 9.9% to 4.1%. The experts also analyzed data on a separate phase 3 trial and a phase 2 trial.
Isao Teshirogi, PhD, Shionogi president and CEO, said in the release, "Patients with cUTIs caused by Gram-negative pathogens continue to face a serious challenge with high morbidity and mortality rates. If approved, we believe cefiderocol could help address a significant unmet need in an area with limited treatment options to fight these life-threatening infections."
Cefiderocol is a siderophore cephalosporin with a novel method of penetrating the tough outer membrane of gram-negative bacteria, including carbapenem-resistant pathogens. It is eligible to be fast-tracked for FDA approval.
The FDA is not bound by the committee's vote but typically follows its recommendations.
Some committee member said any FDA approval should carry with it a boxed warning on the drug's label, the strongest the agency uses, according to a story yesterday by MedPage Today. The two committee members who voted no—Peter Weina, MD, PhD, of Defense Health Headquarters in Falls Church, Virginia and Susanne May, PhD, with the University of Washington in Seattle expressed safety concerns and said more research is needed.
Oct 16 Shionogi news release
Oct 16 MedPage Today story
Antibiotic prescribing high for non-bacterial respiratory illness in Japan
About one third of Japanese patients with non-bacterial acute respiratory tract infections (NB-ARTIs) are inappropriately prescribed antibiotics, according to a new study in PLOS One.
The observational study used longitudinal claims data between April 2012 and June 2017. Though the monthly antibiotic prescribing rate per 100 NB-ARTI consultations decreased by 19.2% during the study period, the authors said the average monthly rate was still 31.65 prescriptions per 100 NB-ARTI consultations.
"Approximately 89% of antibiotics prescribed for NB-ARTI during the study period were broad-spectrum antibiotics, specifically third-generation cephalosporins (40.1%), macrolides (34.1%), and fluoroquinolones (14.4%)," the authors said. Adults ages 19 to 29 were the most likely to be prescribed antibiotics for NB-ARTI.
The diagnoses that yielded the highest antibiotic prescriptions were acute bronchitis and acute tonsillitis.
"Identified factors associated with inappropriate antibiotic prescription in our study, such as patients of working-age, clinic types, and specialties of clinics may be associated with patient expectation for antibiotics, time pressure, and diagnostic uncertainty, respectively," the authors concluded.
Oct 16 PLOS One study