4 October 2018 - MAA submission for both community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.

Paratek Pharmaceuticals today announced the acceptance of the submission to the EMA of the marketing authorisation application for omadacycline. Paratek is seeking approval of omadacycline, a modernized tetracycline, for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Omadacycline is a once-daily oral and intravenous (IV) broad spectrum antibiotic approved under the trade name Nuzyra in the United States.

The MAA is supported by the company’s Phase 3 program for omadacycline, which included three pivotal registration studies: two studies in ABSSSI and one study in CABP. Omadacycline met all required EMA primary endpoints in each study and demonstrated a generally safe and well-tolerated profile.

Read Paratek Pharmaceuticals press release