Aug 6 (Reuters) - A new antibiotic from Paratek Pharmaceuticals Inc is not inferior to current treatments for bacterial skin infections and pneumonia, U.S. Food and Drug Administration staff reviewers said on Monday.
The comments come two days ahead of an advisory committee meeting that will evaluate the safety and effectiveness of the drug, omadacycline.
The company’s shares rose 2 percent to $10 before the bell.
However, FDA staff flagged safety concerns observed in the trial testing omadacycline as a treatment for community acquired bacterial pneumonia.
"Of concern is the imbalance in mortality ... This mortality imbalance in a randomized controlled trial is noteworthy," staffers said here
There has been a push to develop new antibiotics as the United States faces growing concerns over resistance to current antibiotic treatments.
At least 2 million people become infected annually with bacteria that do not respond to treatment with existing drugs, according to the Centers for Disease Control and Prevention. (Reporting by Tamara Mathias in Bengaluru; Additional reporting by Manas Mishra)