Paratek's Omadacycline May Face Mortality Questions With Proposed Pneumonia Indication
US FDA advisory committee will consider "noteworthy" imbalance in deaths in Paratek's trial in community-acquired bacterial pneumonia; agency could not determine cause, briefing documents note.
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Company still mulling pricing for broad-spectrum antibiotic Nuzyra (omadacycline), which is set to launch in the US in the first quarter, following FDA approval Oct. 2.
If moxifloxacin, the comparator in omadacycline's CABP trial, is thought to have an unusually low mortality rate, then the mortality imbalance seen between arms in the study may not seem so worrying.
Most FDA advisory committee members say potential mortality issue seen in community acquired bacterial pneumonia patients can be addressed postmarket.