17 October 2019 - Application approvable by EMA for skin infections based on two Phase 3 studies.
Paratek Pharmaceuticals announced today that the company has withdrawn its submission to the EMA of the marketing authorisation application for Nuzyra (omadacycline).
Based on the review of the data and the application, the EMA has recommended approval for Nuzyra for the treatment of acute bacterial skin and skin structure infections but not for community-acquired bacterial pneumonia. The EMA noted a second study is required for this indication; this position is consistent with EU guidance that typically requires two phase 3 studies per indication for approval.