Spring Intro 2023

23/03/2023

An Example to discuss - cefiderocol

1. Subgroup analysis for MBL producing pathogens

Similar to France, but does not exclude Acinetobacter

The Organisation for Professionals in Regulatory Affairs

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An Example to discuss - cefiderocol

The case of Italy – the power of RWE

1. Initial submission in 2020 with clinical trial data + single arm cohorts • Conditional innovation for carbapenem resistant population

2. COVID drove high levels of hospitalizations and nosocomial superinfections 1. Higher levels of superinfections were observed particularly with CRAB 2. Higher levels of use of reserve antibiotics, particularly cefiderocol 3. Local hospitals published independently 2 case control studies comparing cefiderocol vs SoC

3. Resubmission in 2022 with meta-analysis of published RWE 1. Full innovation granted for patients with CRAB and MBL producing pathogens

The Organisation for Professionals in Regulatory Affairs

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