Paratek Pharmaceuticals’ experimental antibiotic used to treat skin infections and pneumonia received recommended approval by a Food and Drug Administration advisory panel.
The FDA’s Antimicrobials Drug Advisory Committee voted 17-to-1 to recommend approval of the new drug candidate, an antibiotic called omadacycline, for the treatment of acute bacterial skin and skin structure infections. The committee voted 14-4 to recommend approval of omadacycline for the treatment of community-acquired bacterial pneumonia, writes John George in the Philadelphia Business Journal.
Based in Boston but with a strong presence in King of Prussia, Paratek developed omadacycline as a once-daily IV and oral broad spectrum antibiotic and described it as a “moderinized tetracycline.”
“Omadacycline has the potential to help address the urgent and growing need for new antibiotics to treat serious community-acquired infections,” said Michael F. Bigham, chairman and CEO of Paratek.
Bigham said once-daily dosing for omadacycline may help facilitate the early discharge of hospitalized patients or, in other cases, allow for safe and effective treatment of patients in outpatient settings.
“Today’s recommendations from the advisory committee move us one step closer to making this new treatment option available to patients and physicians,” he said. “We look forward to working with the FDA as it considers the comments from the committee members and completes its review of the omadacycline new drug applications.”
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