
Omadacycline Granted Priority Review by FDA
Paratek’s omadacycline moves another step toward approval.
Paratek Pharmaceuticals’ New Drug Applications (NDA) for the intravenous (IV) and oral forms of its once-daily broad-spectrum investigational antibiotic, omadacycline, has been accepted and granted priority review by the US Food and Drug Administration (FDA). The company filed the NDAs in early February 2018.
Omadacycline is the first antibiotic in a new class of tetracycline antibiotics called aminomethylcyclines. Paratek is seeking its approval to treat community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Priority review was given to the NDAs because there is an urgent unmet need for new agents to treat these 2 infections.
The results of
The FDA stated in the NDA acceptance letter that currently, there were no filing or potential review issues that had been identified. An advisory committee will be held to further review the applications.
Evan Loh, MD, president, chief operating officer and chief medical officer of Paratek spoke about the approval in a
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