Ketek® to be launched in Germany
Ketek® (telithromycin), the first in a new class of antibiotics called ketolides, will be launched this week in Germany. Germany becomes the first launch country for Ketek worldwide following the granting of the marketing authorization for the product by the European Commission in July of this year. Ketek was approved for the treatment of community-acquired upper and lower respiratory tract infections, including those caused by bacteria resistant to commonly used antibiotics.
Ketek (800 mg oral dose once daily) is specifically approved for the treatment of patients 18 years and older for community-acquired pneumonia (CAP), mild or moderate; acute exacerbation of chronic bronchitis (AECB); acute sinusitis; and tonsillitis/pharyngitis caused by Group A beta streptococci, as an alternative when beta lactam antibiotics are not appropriate, in patients 12 years and older. Ketek is well tolerated and shows a safety profile comparable to currently used antibiotics. In Phase III studies, the most commonly reported adverse events associated with Ketek were diarrhea, nausea, dizziness and vomiting.
Ketek was developed specifically to offer coverage in upper and lower respiratory tract infections, including those caused by resistant pathogens, with a short and reliable once-daily regimen. Ketek, as the first ketolide to reach the market, is a novel addition to the macrolide-lincosamide-streptogramin (MLSb) group of antibiotics. In vitro data (which don’t necessarily correlate to clinical response) suggest that Ketek combats resistant bacteria by inhibiting the protein synthesis necessary for bacterial reproduction by binding at two different sites on bacterial ribosomes and by inhibiting the ribosome assembly.
Aventis anticipates additional launches of Ketek in other European countries in the coming weeks and months.
Weitere News aus dem Ressort Forschung & Entwicklung
