FDA approves Melinta’s Kimyrsa for skin infections

Melinta Therapeutics of Morristown, New Jersey, announced yesterday that the US Food and Drug Administration (FDA) has approved Kimyrsa (oritavancin) for treatment of adult patients with acute bacterial skin and skin-structure infections (ABSSSIs) caused by susceptible gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA).

Kimyrsa delivers a complete course of the lipoglycopeptide antibiotic oritavancin in a single, 1-hour 1,200 milligram (mg) intravenous infusion. The drug is an updated version of Orbactiv, which was approved by the FDA in 2014 for treatment of ABSSSIs and is infused over 3 hours.

The safety and efficacy of Kimyrsa was previously established in randomized clinical trials that showed that a single 1,200 mg infusion of Orbactiv was as effective 7 to 10 days of twice daily vancomycin in treating 1,987 ABSSSI patients, including 405 with documented MRSA infection. FDA approval was based on a pharmacokinetics study that showed the safety profile was favorable to Orbactiv.

Melinta says it plans to launch the drug this summer.

“We have responded to the requests of the medical community to provide an oritavancin product with a shorter infusion time,” Melinta President and CEO Christine Ann Miller said in a company press release. “We believe that with the approval of Kimyrsa and product availability this summer, physicians and patients will now have a compelling new one-dose alternative to the current standard of multi-dose regimens for ABSSSI.”

Nearly 14 million US patients develop ABSSSIs each year, with more than 3 million emergency department visits. The infections cost US hospitals roughly $4 billion annually.
Mar 15 Melinta press release

Central line-associated bloodstream infections rise during pandemic

A new study from researchers with the US Centers for Disease Control and Prevention shows a significant increase in central line–associated bloodstream infections (CLABSIs) in US acute care hospitals during the early months of the COVID-19 pandemic.

Published yesterday in Infection Control & Hospital Epidemiology, the study analyzed 13,136 inpatient units from 2,986 acute care hospitals and found that the standardized infection ratio (SIR) for CLABSI’s in April, May, and June of 2020 climbed by 28% compared with the same months in 2019, from 0.68 to 0.87. Critical care units saw the greatest percentage increase (39%) in SIR, from 0.75 in 2019 to 1.04 in 2020, and ward locations experienced the second highest increase (13%). Critical care locations had the highest number of CLABSIs in the second quarter of 2020, with 1,911.

Among ward types, significant increases in the SIR occurred in pediatric medical-surgical wards (118%), neurosurgical critical care (108%), medical critical care (60%), and medical-surgical critical care (59%). The highest regional SIR in the second quarter of 2020 (1.07) was in the Upper Northeast and represented a 45% increase compared with 2019. Hospitals of all bed sizes saw increases in SIR.

The study authors say the changes in infection control practices that were made at acute care hospitals to accommodate increasing numbers of patients during the pandemic may have contributed to the increase in CLABSIs. From 2015 through 2019, there was a 31% decline in the national SIR for CLABSIs.

“The findings of this paper highlight a substantial increase in CLABSIs in hospitals throughout the United States coinciding with the COVID-19 pandemic,” they wrote. “The results of this analysis can be used to understand the increase in HAI burden being placed on the nation’s healthcare system and to prioritize ongoing efforts to prevent infections and to drive patient safety.”
Mar 15 Infect Control Hosp Epidemiol abstract

US school districts adopt antibiotic use standard for turkey products

An organization representing the 15 largest school districts in the United States announced last week that it is issuing a standard for responsible antibiotic use in turkey products sold to schools.

Under the new policy, the Urban School Food Alliance (USFA) will require that all turkey products purchased by its schools must be produced under a US Department of Agriculture process verified program that includes compliance with the Certified Responsible Antibiotic Use Standard (CRAU), which was developed in 2014 to minimize antibiotic use in poultry and give schools the option to buy poultry raised with responsible antibiotic use. The turkey industry is the most intensive user of medically important antibiotics, according to research from the Natural Resources Defense Council.

Poultry producers in conformance with CRAU are prohibited from administering antibiotics pre-hatch and from using medically important antibiotics for disease prevention, growth promotion, feed efficiency, or weight gain. They can only use medically important antibiotics to treat poultry diagnosed with a bacterial disease or control disease in poultry exposed to infectious bacteria.

Turkey is the second most served protein in USFA schools, which serve nearly 4 million students daily. The group issued a similar standard for chicken in 2014.

“Issuing this standard for responsible antibiotic use in turkey is the next step in the Urban School Food Alliance’s commitment to provide the healthiest food to students in all its member districts,” Katie Wilson, PhD, USFA Executive Director, said in a press release. “By leveraging the collective purchasing power of Alliance districts, this standard sends an important message to the turkey industry and helps to improve the quality of food sold to the school marketplace.”
Mar 11 USFA press release