Nabriva Wants To Try A Different Approach To Antibiotic Stewardship
Nabriva sees an opportunity for its Phase III antibiotic lefamulin to be used as a first-line agent against community-acquired bacterial pneumonia, rather than being held in reserve, because it targets pathogens that cause lung infections.
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Lefamulin was approved in the US to treat community-acquired bacterial pneumonia, providing a needed IV and oral drug initially in the hospital setting, but new antibiotics have been a tough sell.
With a pair of Phase III trials demonstrating lefamulin’s non-inferiority to moxifloxacin in CABP, Nabriva plans to file an NDA later this year. But Nabriva’s share price fell during the day, perhaps due to safety concerns about the first-in-class antibiotic.
Broad spectrum antibiotic candidates for hospital use dominate the late-stage pipeline under the US FDA's Qualified Infectious Disease Product (QIDP) program, despite efforts to target limited populations of patients and pathogens.