Drug Overview
Factive (gemifloxacin mesylate; Vansen Pharma) is an oral synthetic broad-spectrum antibacterial agent related to the fluoroquinolone class of antibiotics. The drug’s bactericidal efficacy stems from its ability to disrupt bacterial DNA replication, repair, and transcription, resulting in bacterial death. The main mechanism behind this is associated with the drug’s ability to bind equivalently to bacterial topoisomerase II (DNA gyrase) and bacterial topoisomerase IV. This dual targeting has also been associated with the reduced likelihood of selecting resistance towards the drug among bacterial strains. Factive has shown in vitro and clinical antibacterial efficacy against a range of Gram-positive strains commonly encountered in CAP, such as Streptococcus pneumonia, including multidrug-resistant strains resistant to penicillin, second-generation cephalosporins, macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. The drug has also demonstrated efficacy against a range of Gram-negative strains, including Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumonia, and Moraxella catarrhalis, as well as some atypical bacterial strains associated with CAP such as Chlamydia pneumonia and Mycoplasma pneumonia.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Factive : Community-acquired pneumonia
LIST OF FIGURES
6 Figure 1: Factive – development overview
10 Figure 2: Factive for community-acquired pneumonia – SWOT analysis
11 Figure 3: Datamonitor Healthcare’s drug assessment summary of Factive in communityacquired
pneumonia
12 Figure 4: Datamonitor Healthcare’s drug assessment summary for Factive in communityacquired
pneumonia
LIST OF TABLES
4 Table 1: Factive drug profile
8 Table 2: Overview of pivotal trial data for Factive in community-acquired pneumonia