New Antibiotic Baxdela Gets FDA Approval
The Food and Drug Administration (FDA) has approved Baxdela (delafloxacin; Melinta Therapeutics) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.
Baxdela, a fluoroquinolone antibiotic, is active against both Gram-positive and Gram-negative bacteria, including methicillin-resistant Staphylococcus aureus. It is available for both oral and intravenous (IV) use.
The approval of Baxdela was supported by two Phase 3 studies in patients with ABSSSI. In both trials, Baxdela monotherapy (oral and IV) was found to be statistically non-inferior to vancomycin + aztreonam for the primary endpoint of early clinical response at 48–72 hours. In Trial 1, 78.2% of patients in the Baxdela (300mg IV) group were responders versus 80.9% of the vancomycin 15mg/kg + aztreonam group (treatment difference: –2.6). In Trial 2, 83.7% of patients in the Baxdela (300mg IV and 450mg oral) group were responders compared to 80.6% of the vancomycin 15mg/kg + aztreonam group (treatment difference: 3.1).
Baxdela for injection is supplied as a sterile, lyophilized powder in 300mg single-dose vials. The oral tablets are available in a 450mg strength in 20-count bottles. The 450mg tablet is bioequivalent to, and interchangeable with, the 300mg IV dose.
“Approval of new therapies like Baxdela, which is effective against MRSA and other serious pathogens, provides physicians another option in addressing the challenges of ABSSSI patients,” said Dr. David Hooper, professor of medicine, Harvard University, and chief of Infection Control, associate chief, Division of Infectious Diseases, Massachusetts General Hospital.
For more information visit Melinta.com.