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# FDA Approves New Treatment for Pneumonia
- URL: https://www.fdaweb.com/fda-approves-new-treatment-for-pneumonia/
- Published: 2023-05-23T12:00:00.000Z
- Updated: 2026-09-14T18:33:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154520

FDA has approved an Entasis Therapeutics NDA for Xacduro (sulbactam and durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of *Acinetobacter baumannii-calcoaceticus* complex. Sulbactam is structurally related to penicillin and durlobactam protects sulbactam from being degraded by enzymes that may be produced by *A. baumannii*, an [FDA release](https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-pneumonia-caused-certain-difficult-treat-bacteria?ref=fdaweb.com) says. The antibiotic is approved for patients 18 years of age and older.

The agemcy says Xacduro’s approval was based on data from a non-inferiority [clinical trial](http://email.prnewswire.com/ls/click?upn=OXp-2BEvHp8OzhyU1j9bSWuwMvMWelqIco5RbfBrouY-2BQBTugTP-2F-2BYGLqJdSpPZcnnLoGUTG2QNYaRVe1LHY8vZfaGiy9B3L2X9qwMzUHD9B8YYVktl0LqMvZXF0tTUHWLMTYjhXct-2BxhG2VCJiqcygPycGHDyB5Du-2FTEG75sNawq3L9uAe7NglZ7vXaRdgSgGgdY-2FjA6LPbFzpAnaZwxnrQ-3D-3DgJX0%5Ff0D7hj0BJ4b-2F7NuVqzPDs7FGiq8VLIwAX0sPSotqoLJejYqb1dmQHyCXe45PgGWVjS1PBgz9EAXpSF2icRRGWRcE38ldCki3SvXRCinWPGtznu7v-2FQarYokRyyej4n8-2FTx-2FEh4ePm5xFW0Vg5mzhbZnMsjntHbBfwe2Kv5eIr-2Bx83eR5W9X3pY2Zja1PCjNten309uUN4Xoqn6ZmheJqitbfrYcgxJiu-2B21lWOQey0dPJs3inF1WH43bOEMcZBfmTkloWdzEPedIy9zTc5SDzjySKv7TCq-2FLOvfabrrPdfp49vPjSXVtB3e6N2hLrlGp1sgzen6jLEvHz59-2BfzqE5WBPDBGYxzFK983ZbPfwbA8-3D&ref=fdaweb.com) in 177 hospitalized adults with pneumonia caused by carbapenem-resistant *A. baumannii*. “The primary measure of efficacy was mortality from all causes within 28 days of treatment in patients with a confirmed infection with carbapenem-resistant *A. baumannii*,” it says. “Of those who received Xacduro, 19% (12 of 63 patients) died, compared to 32% (20 of 62 patients) who received colistin; this demonstrated that Xacduro was noninferior to colistin.”

The most common adverse reaction reported in the trial was liver function test abnormalities. “Xacduro comes with certain warnings and precautions, such as hypersensitivity reactions and *Clostridiodes* *difficile*\-associated diarrhea,” the agency says.