On April 3, the U.S. Food and Drug Administration (FDA) approved ceftobiprole medocaril sodium for injection (Zevtera) to treat adult patients with acute bacterial skin and skin structure infections. The therapy was approved after researchers demonstrated its efficacy in a multinational trial involving 679 patients randomly assigned to receive either ceftobiprole medocaril sodium (n = 335) or vancomycin plus aztreonam (n = 344). Early clinical response was defined as a reduction of primary skin lesions by at least 20%, survival for at least 72 hours, and the absence of additional antibacterial treatment or unplanned surgery. Compared with those who received vancomycin plus aztreonam, those who received ceftobiprole medocaril sodium experienced an early clinical response rate of 91.3% vs 88.1% within 48 to 72 hours of treatment initiation. The most common side effects in patients receiving ceftobiprole medocaril sodium were rashes, headaches, nausea, vomiting, diarrhea, injection site reactions, increased hepatic enzymes and bilirubin levels, and dysgeusia. Ceftobiprole medocaril sodium was granted Priority Review, Fast Track, and Qualified Infectious Disease Product designations. “[Ceftobiprole medocaril sodium] will provide an additional treatment option for a number of serious bacterial infections,” concluded Peter Kim, MD, MS, Director of the Division of Anti-Infectives at the Center for Drug Evaluation and Research at the FDA.
April 17, 2024