The U.S. Food and Drug Administration has approved Basilea Pharmaceutica International Ltd.’s new Zevtera Antibiotic (ceftobiprole medocaril sodium for injection) for three different bacterial infections.
Following the news, Basilea shares were gaining around 8 percent in the morning trading in Switzerland on Thursday, and around 14 percent on London Stock Exchange.
In a statement, the agency noted that it has approved the injection for the treatment of adults with Staphylococcus aureus bloodstream infections (bacteremia) or SAB, including those with right-sided infective endocarditis. The approval also includes as treatment for adults with acute bacterial skin and skin structure infections or ABSSSI, as well as for adult and pediatric patients three months to less than 18 years old with community-acquired bacterial pneumonia or CABP.
Zevtera was granted Priority Review, Fast Track and Qualified Infectious Disease Product designations for the CABP, ABSSSI and SAB indications.
Peter Kim, director of the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation and Research, said, “The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Zevtera will provide an additional treatment option for a number of serious bacterial infections.”
Zevtera’s efficacy in treating SAB was evaluated in a randomized, controlled, double-blind, multinational, multicenter trial. In the trial, a total of 69.8 percent of subjects who received Zevtera achieved overall success compared to 68.7 percent of subjects who received the comparator.
In ABSSSI, Zevtera’s efficacy was evaluated in a randomized, controlled, double-blind, multinational trial. Of the subjects who received Zevtera, 91.3 percent achieved an early clinical response within the necessary timeframe, compared to 88.1 percent of subjects who received the comparator.
Further, Zevtera’s efficacy in treating adult patients with CABP was evaluated in a randomized, controlled, double-blind, multinational, multicenter trial. Of the subjects who received Zevtera, 76.4 percent achieved clinical cure compared to 79.3 percent of subjects who received the comparator. An additional analysis considered an earlier timepoint of clinical success at Day 3, which was 71 percent in patients receiving Zevtera and 71.1 percent in patients receiving the comparator.
The FDA noted that given the similar course of CABP in adults and pediatric patients, the approval of Zevtera in pediatric patients three months to less than 18 years with CABP was supported by evidence from the CABP trial of Zevtera in adults and a trial in 138 pediatric subjects three months to less than 18 years of age with pneumonia.
Patients with a known history of severe hypersensitivity to ceftobiprole or any of the components of Zevtera, or other members of the cephalosporin antibacterial class are asked not to use Zevtera.
Warnings and precautions for Zevtera include increased mortality in ventilator-associated bacterial pneumonia patients (an unapproved use), hypersensitivity reactions, seizures and other central nervous system reactions and Clostridioides difficile-associated diarrhea.
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