HQ Team
April 4, 2024: The USFDA approved Swiss-based Basilea Pharmaceutica International’s Zevtera injection for the treatment of staphylococcus aureus bloodstream infections and skin infections in adults and community-acquired bacterial pneumonia in patients three months to 18 years, and adults.
The regulator cleared the drug after evaluation of Zevtera’s efficacy in 390 participants during a trial.
The primary measure of efficacy for this trial was the “overall success —defined as survival, symptom improvement, staphylococcus aureus bacteremia bloodstream clearance, no new staphylococcus aureus bacteremia complications and no use of other potentially effective antibiotics— at the post-treatment evaluation visit, which occurred 70 days after being randomly assigned an antibiotic.
“A total of 69.8% of subjects who received Zevtera achieved overall success compared to 68.7% of subjects who received the comparator,” according to an emailed statement from the USFDA.
91.3% rate for acute skin infections
For the acute bacterial skin and skin structure infections trial, 679 participants were tested with Zevtera or vancomycin plus aztreonam (the comparator). “The primary measure of efficacy was early clinical response 48-72 hours after the start of treatment.
“Of the subjects who received Zevtera, 91.3% achieved an early clinical response within the necessary timeframe compared to 88.1% of subjects who received the comparator.”
The injection to test Zevtera’s efficacy in treating adult patients with community-acquired bacterial pneumonia was evaluated in 638 adults hospitalized with CABP and requiring IV antibacterial treatment for at least three days to receive either Zevtera or the comparator ceftriaxone with optional linezolid.
In participants who received Zevtera, 76.4% achieved clinical cure compared to 79.3% of subjects who received the comparator.
“An additional analysis considered an earlier timepoint of clinical success at Day 3, which was 71% in patients receiving Zevtera and 71.1% in patients receiving the comparator,” according to the statement.
Antimicrobial resistance
All three infections fall broadly under antimicrobial resistance. Antimicrobial resistance — the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug— is a serious, complex and costly public health problem.
According to the Centers for Disease Control and Prevention, each year in the US about 2.8 million antibiotic-resistant infections occur, and more than 35,000 people die as a result.
The FDA will continue to be “committed to fostering new antibiotic availability when they prove to be safe and effective, and Zevtera will provide an additional treatment option for several serious bacterial infections,” said Peter Kim, MD, MS, director of the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation and Research.
Zevtera comes with certain warnings and precautions such as 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.
