FDA approves new treatment for nosocomial pneumonia
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Key takeaways:
- The FDA approved sulbactam-durlobactam for nosocomial pneumonia caused by drug-resistant Acinetobacter baumannii.
- The CDC and WHO have designated these infections significant threats to public health.
The FDA has approved IV sulbactam-durlobactam to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex.
The treatment is marketed by Innoviva as Xacduro.
“[The] approval helps address a high, unmet need by providing an additional treatment option for some of the sickest patients in our nation’s hospitals,” Peter Kim, MD, MS, director of the FDA’s Division of Anti-Infectives, said in a press release.
The FDA’s Antimicrobial Drugs Advisory Committee in April voted unanimously in favor of approving the IV treatment to combat A. baumannii, which the CDC has designated as an urgent threat to public health and WHO has designated a priority pathogen.
Healio | Infectious Disease News Editorial Board Member Keith S. Kaye, MD, MPH, professor of medicine and chief of the division of allergy, immunology and infectious diseases at the Rutgers Robert Wood Johnson Medical School, told Healio that A. baumannii contaminates the environment and is a “pretty hearty pathogen that is difficult to eradicate and can spread from patient to patient pretty easily.”
In the United States, carbapenem-resistant Acinetobacter causes approximately 8,500 infections in hospitalized patients and roughly 700 deaths per year, according to the CDC.
Because it can develop drug resistance easily — according to Kaye, more than half of Acinetobacter strains are resistant to first-line carbapenems, and there are limited treatment options beyond that — sulbactam-durlobactam’s approval is “monumental,” he said.
“I think sulbactam-durlobactam offers the first effective, safe option for these highly resistant strains of Acinetobacter that we’ve seen,” Kaye said. “The durlobactam basically restores the sulbactam activity and what you end up with is another first-line treatment option for Acinetobacter, as before we were using either unproven therapies, toxic therapies or therapies that had major limitations. So, this is a major step forward.”
The approval was based on positive results from the two-part phase 3 ATTACK trial assessing safety and efficacy of the drug compared with colisitin in patients with Acinetobacter infections.
In the first part of the study, researchers found that 28-day all-cause mortality was 13.2 percentage points lower among patients who received sulbactam-durlobactam compared with colistin, and the clinical cure rate was 21.6 percentage point higher for patients in the sulbactam-durobactam group than in the colistin group.
The second part found sulbactam-durlobactam was safe and had a lower overall incidence of treatment-emergent adverse events.
Kaye said Acinetobacter “wreaks havoc” in hospitals.
“The most important thing is [that for] patients who develop these devastating infections, we have a very good treatment that is not toxic to the kidneys, is safe and effective when available,” Kaye said. “More effective treatment will certainly help in containing spread and, certainly, when there are outbreaks, provide effective treatment options to try to quell the impact of this difficult-to-treat pathogen.”
References:
- CDC. Healthcare-associated infections: Acinetobacter. https://www.cdc.gov/hai/organisms/acinetobacter.html. Accessed May 24, 2023.
- FDA. FDA approves new treatment for pneumonia caused by certain difficult-to-treat bacteria. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-pneumonia-caused-certain-difficult-treat-bacteria. Published May 23, 2023. Accessed May 24, 2023.
- Innoviva. Innoviva specialty therapeutics announces FDA approval for Xacduro (subactam for injection; durlobactam for injection), co-packaged for intravenous use. https://innovivaspecialtytherapeutics.com/241-2/. Published May 23, 2023. Accessed May 24, 2023.
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