On April 3, the FDA approved Zevtera, an antibiotic, for the treatment of adults with bacteremia (SAB), acute bacterial skin and skin structure infections (ABSSSI), and pediatric patients with community-acquired bacterial pneumonia (CABP).
Zevtera’s efficacy in all three uses was evaluated in clinical trials. For SAB, researchers found that 69.8% of subjects who received the medication achieved “overall success” at the post-treatment evaluation visit, compared to 68.7% of subjects who received the comparator. For ABSSSI, 91.3% of subjects “achieved an early clinical response within the necessary timeframe,” defined as a “reduction of the primary skin lesion by at least 20%, survival for at least 72 hours, and the absence of additional antibacterial treatment or unplanned surgery,” compared to 88.1% of subjects who received the comparator. For adults with CABP, researchers found that 76.4% of subjects “achieved clinical cure” compared to 79.3% of subjects who received the comparator. “Given the similar course of CABP in adults and pediatric patients,” Zevtera was approved for use in pediatric patients, supported as well by a trial of 138 pediatric subjects.
Zevtera’s side effects include nausea, anemia, diarrhea, and increased levels of hepatic enzymes, but the side effects vary depending on what the patient is being treated for.
FDA’s website has the release.
