FDA Approves New Antibiotic to Treat Three Different Infections

The Food and Drug Administration (FDA) has approved Zevtera — a new antibiotic that works on three different bacterial and fungal infections that can be hard to treat.

On April 3, the FDA announced its approval of Zevtera to treat Staphylococcus aureus bloodstream infections in adults, acute bacterial skin and skin structure infections in adults, and community-acquired bacterial pneumonia in adult and pediatric patients who are at least three months old.

The new antibiotic, manufactured by Swiss drugmaker Basilea Pharmaceutica and medically named ceftobiprole medocaril, is administered by injection.

“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,” said Peter Kim, M.D., M.S., director of the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation and Research, in a news release.

Clinical trials

The drug’s ability to effectively treat the three listed infections was validated in several separate clinical trials.

To test the treatment of Staphylococcus aureus bloodstream infections, including those with right-sided infective endocarditis, researchers conducted a randomized, controlled, double-blind, multinational, multicenter trial on 390 subjects. They randomly assigned 192 participants to receive Zevtera and 198 participants to receive other antibiotics typically used to treat this kind of infection.

At a post-treatment evaluation visit 70 days after receiving one of the antibiotics, researchers examined whether the subjects had survived, seen symptom improvement, rid their bloodstream of S. aureus bacteremia, experienced any new S. aureus bacteremia complications, and used another potentially effective antibiotic. They found that a total of 69.8% of subjects who received Zevtera achieved overall success, compared to 68.7% of subjects who received the comparator.

Researchers also conducted a trial to evaluate the treatment of adults with acute bacterial skin and skin structure infections. They randomly assigned 335 people to receive Zevtera and 344 to receive another comparable antibiotic which is typically prescribed for this kind of infection. Of the subjects who received Zevtera, 91.3% experienced 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 other drug.

For community-acquired bacterial pneumonia (CABP) in adults, researchers randomly assigned 314 adults hospitalized with CABP and requiring IV antibacterial treatment for at least three days to receive Zevtera and gave 324 patients the comparable drug. Of the subjects who received Zevtera, 76.4% achieved clinical cure between seven and 14 days after end-of-treatment, compared with 79.3% of subjects who received the comparator.

“Given the similar course of CABP in adults and pediatric patients, today’s 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,” the FDA said.

The antibiotic can cause a number of side effects, which differ depending on the reason for use, though some of the most common ones include nausea, vomiting, diarrhea.

The FDA says patients should not use Zevtera if they have a known history of severe hypersensitivity to ceftobiprole or any of the components of Zevtera, or other members of the cephalosporin antibacterial class.

The Zevtera label features certain warnings and precautions, including 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.