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PTJA11 – Cefiderocol for the treatment of infections due to aerobic Gram-negative bacteria in adult patients with limited treatment options – Final assessment now available

This is the pharmaceutical Joint Assessment PTJA11 – Cefiderocol for the treatment of infections due to aerobic Gram-negative bacteria in adult patients with limited treatment options. In April 2020, the European Commission granted marketing authorisation for Fetcroja® (cefiderocol) for the treatment of infections due to aerobic Gram-negative bacteria in adult patients with limited treatment options. This Joint Assessment aims to compare the clinical effectiveness and safety of cefiderocol in the target patient populations with relevant comparators according to the national requirements of EUnetHTA partners.

Below is the documentation provided by the Joint Assessment authoring team (project plan, assessment report and responses to the factual accuracy check performed by Shionogi) and by Shionogi, the Marketing Authorisation Holder of cefiderocol (PTJA11 submission dossier).

For any questions regarding the assessment, please contact WP4_Pharmaceuticals@zinl.nl

Due to the COVID-19 outbreak and impact of related measures on the involved HTA agencies, the AIFA team had to withdraw from its authoring role in the joint assessment of cefiderocol. EUnetHTA would like to acknowledge the contribution of the Italian team in the entire scoping phase, including the elaboration of the PICO and finalisation of the project plan. Please see the EUnetHTA COVID-19 response here.

PTJA11 – Final Project Plan​​

PTJA11 – Final Assessment Report

PTJA11 – MAH Core Submission Dossier

PTJA11 – External Comments – Factual Accuracy Check MAH