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FDA approves new antibiotic for children, adults with community-acquired bacterial pneumonia

April 3, 2024

The Food and Drug Administration has approved a new antibiotic for children and adults with community-acquired bacterial pneumonia (CABP).

Zevtera (ceftobiprole medocaril sodium for injection) from Basilea Pharmaceutica International Ltd. can be used in patients as young as 3 months with CABP. It also was approved for adults with Staphylococcus aureus bloodstream infections (bacteremia) and adults with acute bacterial skin and skin structure infections.

The FDA’s approval of Zevtera comes amid a shortage of amoxicillin oral powder for suspension.

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

In a trial of 138 pediatric patients with hospital-acquired pneumonia or community-acquired pneumonia, 91% who received Zevtera achieved clinical cure compared to 100% of those who received ceftriaxone.

The FDA’s approval for children also was based in part on a trial in adults who received one of those two treatments. About 71% of each group had clinical success at day 3. At one to two weeks post treatment, 76% of the Zevtera group achieved clinical cure compared to 79% of the ceftriaxone group.

The most common side effects for children receiving Zevtera were vomiting, headache, increased levels of hepatic enzymes, diarrhea, infusion site reaction, vein inflammation and fever.

Zevtera should not be used by 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. Zevtera’s warnings and precautions 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.

Clinicians should be sure their patient needs antibiotics before prescribing them. Most infections in children are caused by viruses, not bacteria.

The Centers for Disease Control and Prevention estimates there are nearly 3 million antibiotic-resistant infections in the U.S. each year, resulting in more than 35,000 deaths. The agency calls antibiotic resistance “one of the most urgent threats to the public’s health.”





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