The FDA has expanded the indication for Teflaro (ceftaroline fosamil; Allergan) to include treatment of acute bacterial skin and skin structure infections in pediatric patients.
Using a broad-range PCR technique targeting 16S ribosomal DNA may improve diagnosis and treatment of bacterial pyomyositis.
Prediction of sepsis via markers such as hypothermia and elevated procalcitonin
may allow for its early detection and management.
The NDA included data from the Phase 3 REVIVE-1 and REVIVE-2 trials.
Although there has been progress in the development of new antibacterial drugs, most of the recently approved agents have been modifications of existing chemical classes of antibiotics.
Nuzyra, an aminomethylcycline (related to tetracycline antibiotics), is designed to overcome tetracycline resistance and has broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria, and other drug-resistant strains.
Omadacycline is noninferior to moxifloxacin for community-acquired bacterial pneumonia and noninferior to linezolid for acute bacterial skin infections.
The approval was based on Phase 3 data from 2 studies in ABSSSI, where treatment with Nuzyra was compared with linezolid, and 1 study in CABP comparing Nuzyra with moxifloxacin. Across all 3 trials, Nuzyra was found to be effective and generally safe and well-tolerated.
The structure of contezolid was designed to potentially reduce the risk of hematological toxicity associated with this class of antibiotics.
The patient, a 42-year-old female with systemic lupus erythematosus treated with mycophenolate mofetil and prednisone, reported swelling and pain in the fifth finger of her left hand for about 1-week.
