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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 previous studies on omadacycline’s activity against ABSSSI and CABP showed that the drug met all required primary endpoints set by the FDA and the European Medicines Agency (EMA). Furthermore, the drug was found to generally safe and well-tolerated.

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 statement released by Paratek saying, “Antibiotic resistance is on the rise, and the need for new antibiotics is urgent. The FDA acceptance of these applications brings us one step closer to providing physicians an important new option in the fight against community-acquired infections. With both oral and IV formulations, omadacycline has the potential to be the first once-daily oral and IV tetracycline antibiotic approved in nearly 20 years. Based upon its demonstrated clinical profile, omadacycline enables physicians to transition their patients from hospital to home faster, thereby reducing overall health care costs.”