Ketek (telithromycin; Sanofi) is an oral semisynthetic antibacterial agent of the ketolide class. The drug, which is the first ketolide to gain regulatory approval for the treatment of community-acquired pneumonia, is structurally related to the macrolide class of antibiotics. It exerts its antibacterial activity by blocking bacterial protein synthesis through binding to the 50S ribosomal subunit. Ketek is able to dually bind to domains II and V on the 23S part of the 50S ribosomal subunit. Ketek’s antibacterial spectrum includes a number of pathogens with clinical significance in respiratory infections, including aerobic Gram-positive organisms such as Streptococcus pneumonia, and Staphylococcus aureus (methicillin-sensitive strains).
Ketek (telithromycin; Sanofi) is the first-to-market of the ketolide class of antibacterial agents. The drug’s enhanced mechanism of action allows it to retain activity against bacterial strains resistant to its structurally related macrolide antibiotics, as well as other older classes of antibacterial agents. Ketek’s activity against some bacterial pathogens with clinical significance in respiratory infections, such as community-acquired pneumonia (CAP), further enhanced its potential appeal in this market. However, the use of Ketek has been associated with multiple safety concerns that have limited its use in certain patient groups such as those with myasthenia gravis, as well as patients with a prior history of jaundice or hepatitis. These factors limited the drug’s overall clinical attractiveness, subsequently limiting its share of the CAP market. Datamonitor Healthcare anticipates that, as new antimicrobial agents with similar efficacy and better safety profiles launch, Ketek’s safety issues will continue to restrict its clinical attractiveness in the CAP market.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Ketek : Community-acquired pneumonia
LIST OF FIGURES
5 Figure 1: Ketek – development overview
9 Figure 2: Ketek for community-acquired pneumonia – SWOT analysis
10 Figure 3: Datamonitor Healthcare’s drug assessment summary of Ketek in community-
11 Figure 4: Datamonitor Healthcare’s drug assessment summary for Ketek in community-
LIST OF TABLES
4 Table 1: Ketek drug profile
7 Table 2: Overview of pivotal trial data for Ketek in community-acquired pneumonia
9 Table 3: Efficacy of Ketek against MDRSP in community-acquired pneumonia
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