Basilea Pharmaceutica’s Zevtera receives FDA approval

04 Apr 2024
www.pharmaceutical-technology.com
Clinical ResultDrug ApprovalPhase 3Qualified Infectious Disease Product
Basilea Pharmaceutica’s Zevtera receives FDA approval
Preview
Source: 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.
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.
See Also:
Japan’s PMDA approves Partner’s inhaled Leukine for aPAP
Basilea Pharmaceutica’s Zevtera receives FDA approval
Preview
Source: Pharmaceutical Technology
EC approves Bristol Myers Squibb’s Reblozyl for first-line MDS treatment
Basilea Pharmaceutica’s Zevtera receives FDA approval
Preview
Source: Pharmaceutical Technology
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.”
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
-
Drugs
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.