USFDA panel backs approval of Paratek's antibiotic for pneumonia
A U.S. Food and Drug Administration (USFDA) expert panel voted in favor of approval of Paratek Pharmaceuticals Inc’s antibiotic to treat bacterial pneumonia and skin infections.
The panel voted 17-1 in favor of the drug’s safety and effectiveness in treating acute bacterial skin and skin structure infections and voted 14-4 for treating community-acquired bacterial pneumonia.
The vote comes ahead of a final decision by the FDA on the drug’s approval, which is expected by early October. The FDA typically follows the recommendations of its advisory panels but is not obliged to do so.
The drug, omadacycline, would be the first of a new class of antibiotics known as aminomethylcyclines and could help in countering growing antibiotic resistance.
Shares of the company were halted ahead of the panel’s vote.
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