Paratek Pharmaceuticals Inc. withdrew an application with the European Medicines Agency for marketing approval of Nuzyra for treating certain infections and a common type of pneumonia.
Paratek withdrew the application after the regulator said it would recommend approving the therapy for acute bacterial skin and skin structure infections but not for community-acquired bacterial pneumonia. The EMA said Paratek would have to complete another study to earn a nod for the pneumonia indication.
The Boston-based biopharmaceutical company said in an Oct. 17 press release that the directive is consistent with the EU body's requirement for two phase 3 studies to secure approval in community-acquired bacterial pneumonia.
The application for Nuzyra, or omadacycline, was supported by a phase 3 program that included three studies, two in the infection indications and one for pneumonia. Those trials met their goals, and the therapy was determined to be safe and well tolerated by patients.
Paratek said securing approval in both indications for Nuzyra remains its top priority to maximize value. The approval would bring with it 10 years of market exclusivity.
Nuzyra, a once-daily oral and intravenous medication, is already approved by the U.S. Food and Drug Administration in acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia.