FDA approves antibiotic to treat three bacterial infections
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Key takeaways:
- The FDA approved ceftobiprole for staph bloodstream infections, acute bacterial skin and skin structure infections and community-acquired pneumonia.
- The approval comes 17 years after the drug was first submitted to the FDA.
The FDA this week approved the antibiotic Zevtera for the treatment of three bacterial infections 17 years after it was first submitted to the agency.
Zevtera (ceftobiprole medocaril sodium for injection, Basilea Pharmaceutica) is now approved to treat adults with Staphylococcus aureus bloodstream infections (SAB) — including those with right-sided infective endocarditis — adults with acute bacterial skin and skin structure infections (ABSSSIs), and adults and children aged 3 months to 18 years with community-acquired bacterial pneumonia (CABP), the FDA and Basilea announced.
Ceftobiprole was initially submitted for approval in 2007, but the FDA rejected its application because of concerns related to clinical trials.
The fifth-generation cephalosporin continued to show promise in clinical trials and gained approval in several European countries, but researchers said it required further investigation.
Basilea submitted a new application in August 2023, which was accepted by the FDA based on data from phase 3 trials for treatment of SAB, ABSSSI and CABP. The FDA designated ceftobiprole as a qualified infectious disease product, making it eligible for fast track and priority review designations. It has 10 years of market exclusivity.
“This approval is a landmark for ceftobiprole and reflects its broad clinical utility,” Marc Engelhardt, MD, chief medical officer for Basilea, said in a press release. “The indication in adult patients with S. aureus bacteremia, including those with right-sided infective endocarditis caused by [methicillin-susceptible S. aureus and MRSA] addresses a real medical need, as current options are limited.”
Ceftobiprole was found to be noninferior to daptomycin in a randomized, controlled trial assessing 390 patients with SAB, with 69.8% of participants in the ceftobiprole group achieving the measures of overall success outlined by the study compared with 68.7% of participants who received daptomycin.
In another randomized, controlled trial that included 679 patients, ceftobiprole was found to be noninferior to vancomycin against ABSSSI, with 91.3% of people who received ceftobiprole achieving the primary measure of efficacy compared with 88.1% who received vancomycin.
For CABP, the FDA considered data from two trials — one in adults and one in children and adolescents aged younger than 18 years. In one trial that included 638 adults, 76.4% of participants who received ceftobiprole achieved clinical cure 7 to 14 days after the end of treatment compared with 79.3% of those who received ceftriaxone. Additionally, researchers considered an earlier time point for clinical success — 3 days — finding that 71% of the ceftobiprole group achieved clinical cure compared with 71.1% in the ceftriaxone group.
The trial conducted among 138 children produced similar data, according to the FDA.
Switzerland-based Basilea is looking for a commercial manufacturing partner in the U.S., saying that it expects to enter into a partnership later this year.
“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, MD, MS, director of the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation and Research, said in a press release.
References:
- Basilea announces US FDA approval of antibiotic zevtera (ceftobiprole medocaril) for three indications. https://www.basilea.com/news#news_1487. Published April 4, 2024. Accessed April 4, 2024.
- Basilea announces submission of a new drug application to the US Food and Drug Administration for its antibiotic ceftobiprole. https://www.basilea.com/news#news_1441. Published Aug. 4, 2023. Accessed April 4, 2024.
- FDA approves new antibiotic for three different uses. https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses. Published April 3, 2024. Accessed April 4, 2024.
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