FDA panel backs omadacycline for pneumoniaSeptember 14, 2018
The Antimicrobials Drug Advisory Committee of the USFDA voted in favour of the approval of omadacycline for the treatment of acute bacterial skin structure infections and community-acquired bacterial pneumonia, Paratek Pharmaceuticals, Inc. announced.
Omadacycline is a modernized tetracycline being developed as a once-daily IV and oral, broad spectrum antibiotic for the treatment of serious community-acquired infections.Omadacycline is specifically designed to overcome tetracycline resistance and exhibits activity across a broad spectrum of bacteria, including Gram-positive, Gram-negative, anaerobes, atypical bacteria, and other drug-resistant strains.
The advisory committee considered data from the omadacycline global development programme, which included three completed Phase 3 studies evaluating the safety and efficacy of the IV and oral formulations of omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP). In all three studies, omadacycline met all primary and secondary efficacy outcomes designated by the FDA and was generally safe and well-tolerated.
Under a research agreement with the U.S. Department of Defense, omadacycline is also being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.