Basilea Pharmaceutica’s Zevtera receives FDA approval

2024-04-04

临床结果上市批准临床3期合格传染病产品

Basilea Pharmaceutica’s Zevtera receives FDA approval

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来源: Pharmaceutical Technology

The efficacy of Zevtera in treating SAB was established through a randomised, controlled, double-blind, multinational, multicentre clinical trial. Credit: Gorodenkoff / Shutterstock.com.

The US Food and Drug Administration (FDA) has approved Basilea Pharmaceutica’s Zevtera (ceftobiprole medocaril sodium for injection), an antibiotic to treat multiple infections.

The antibiotic can be used to treat adults with staphylococcus aureus bloodstream infections (SAB) and acute bacterial skin and skin structure infections (ABSSSI).

It is also indicated for community-acquired bacterial pneumonia (CABP) in adult and paediatric patients from three months old.

The approval comes after the company filed a new drug application for the antibiotic.

The efficacy of Zevtera in treating SAB was established through a randomised, controlled, double-blind, multinational, multicentre clinical trial.

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A total of 390 participants were assigned to receive either Zevtera or daptomycin with optional aztreonam.

Zevtera met the trial’s main efficacy endpoint, achieving an overall success rate of 69.8%, compared to 68.7% in the comparator arm.

For ABSSSI, Zevtera’s efficacy was assessed in a similar randomised, controlled, double-blind, multinational trial with 679 subjects.

Zevtera showed a success rate of 91.3% for early clinical response, versus 88.1% for the vancomycin and aztreonam regimen.

The antibiotic’s efficacy in adult CABP patients was based on a similar study in 638 adults.

Clinical cure rates were 76.4% for Zevtera and 79.3% for ceftriaxone with an optional linezolid arm.

The approval of Zevtera for paediatric CABP patients was based on the adult CABP trial results and a study involving 138 paediatric subjects with pneumonia.

FDA Center for Drug Evaluation and Research anti-infectives director Peter Kim stated: “The FDA is committed to fostering new antibiotic availability when these prove safe and effective, and Zevtera will provide an additional treatment option for serious bacterial infections.

“The FDA will continue our important work in this area as part of our efforts to protect public health.”

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