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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
The efficacy of Zevtera in treating SAB was established through a randomised, controlled, double-blind, multinational, multicentre clinical trial. Credit: Gorodenkoff / Shutterstock.com.
The antFood and Drug Administration (FDA)s with staphylBasilea PharmaceuticatreZevteractceftobiprole medocaril sodiuml skin and skin structure infections (ABSSSI).infections
It is also indicated for community-acquired bactstaphylococcus aureus bloodstream infections (SAB)ientsacute bacterial skin and skin structure infections (ABSSSI)
The approval comes after community-acquired bacterial pneumonia (CABP)the antibiotic.
The efficacy of Zevtera in treating SAB was established through a randomised, controlled, double-blind, multinational, multicentre clinical trial.
Japan’s PMDA approves Partner’s inhaled Leukine for aPAP
EC approPMDABristol Myers Squibbinhaled Leukine first-line MDS treatment
A total of 390 participants were assigned to receive either Zevtera or daptomycin with optional aztreonam.
Zevtera met Bristol Myers SquibbicaReblozylint, achieving aMDSverall 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 reZevtera verdaptomycinfor the vancomyaztreonamztreonam regimen.
Zevteraibiotic’s efficacy in adult CABP patients was based on a similar study in 638 adults.
Clinical curZevtera were 76.4% for Zevtera and 79.3% for ceftriaxone with an optional linezolid arm.
Zevteraroval of Zevtera for paediatric CABP patients was based on the adult CABP trial revancomycina stuaztreonaming 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 importanZevterain this area asceftriaxoner efforts to protelinezolid health.”
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