Agency / resistance examination for September 23, 2022

FDA advisors approve fecal transplant treatment for recurrence Difficult

Swiss biopharmaceutical company Ferring Pharmaceuticals announced yesterday that the Food and Drug Administration (FDA)’s Advisory Committee on Vaccines and Related Biological Products (VRBPAC) has voted in favor of FMT-based therapy.

According to a company press release, VRBPAC voted 13 to 4 that data from the biopharmaceutical license application was sufficient to support the effectiveness of RBX2660 (Rebyota) to reduce the frequency of Clostridium difficile infection (CDI) in adults after antibiotic treatment, and 12 to 1 that the data were sufficient to support the safety of a live, germ-based, therapeutic treatment delivered by enema.

FMT treatment involves transplanting beneficial bacteria into the intestine of a patient with recurrent CDI, which is traditionally treated with antibiotics. FMT has been found in several studies to be an effective treatment for recurrent CDI, and the latest treatment guidelines from the American Infectious Diseases Association recommend it for patients who have had several episodes of recurrent CDI and are not treated with antibiotics.

Up to 35% of CDI cases recur after initial diagnosis, and patients with recurrent CDI have a much higher risk of developing further infection.

“Today’s Advisory Committee vote represents an important milestone in Ferring’s ongoing efforts to address unmet needs for interventions that can reduce the incidence of recurrence. Difficult The infection, which represents a significant health burden for patients, is a significant health burden for patients,” said Miriam Mole Arts, executive vice president and medical director for Ferring Pharmaceuticals, in the statement.

RBX2660 will be the first FMT approved by the Food and Drug Administration.
September 22, Ferring Pharmaceuticals press release

Dialysis patients have four times more C . teams Danger, study found

A systematic review and meta-analysis found that patients with chronic kidney disease who require maintenance dialysis (MHD) have a significantly increased risk of CDI compared to those who do not need an MHD, researchers report today in Infection control and hospital epidemiology.

To assess the potential burden and risk factors for CDI in patients with MHD, who are known to be at increased risk for CDI due to significant exposure to antibiotics and frequent hospitalization, Brown University researchers reviewed 240 studies published prior to March 2022; Fifteen of these studies have provided data on CDI rates among people who need MHD, and 8 have also provided CDI rates among people who don’t need MHD.

The pooled prevalence of CDI among people requiring MHD was 19.14%, compared to 5.16% among people without MHD (odds ratio). [OR], 4.35; 95% confidence interval [CI], 2.07 to 9.16). The linear increase in CDI over time for both groups was significant, increasing at an average rate of 31.97% per year from 1993 to 2017 (OR, 1.32; 95% CI, 1.1 to 1.58). The linear annual increase was similar among subjects with and without MHD (OR, 1.28; 95% CI, 1.13 to 1.45).

Risk factors for the MHD group included age 65 or older, serum albumin levels of 3 grams per deciliter or less, higher Charlson comorbidity index scores, HIV, and bloodstream infections. Mortality associated with CDI was doubled among people requiring MHD, and the mortality rate ranged from 13.2% to 68.8%.

“The high and increasing rates of CDI among people requiring MHD and the associated higher morbidity and mortality compared to those without MHD underscore the importance of prevention. Difficult Prevalence and CDI in this patient group,” the authors wrote.
September 23 Infect Hospital Control Epidemiol study

Leave a Reply

%d bloggers like this: