Ketek (telithromycin), the first in a new class of antibiotics called ketolides, was launched last week in France. Ketek was developed specifically to offer targeted coverage in upper and lower respiratory tract infections, including drug resistant Streptococcus pneumoniae, with a short treatment duration.
Resistance to penicillins and macrolides among common respiratory pathogens continues to increase worldwide. Only about 50 per cent of strains of Streptococcus pneumoniae are fully susceptible to penicillin/or erythromycin in France.
In July 2001, Ketek (800 mg oral dose once daily) received marketing approval in the European Union (EU) for the treatment of patients 18 years and older for community-acquired pneumonia (CAP), mild or moderate; acute exacerbations of chronic bronchitis (AECB); acute sinusitis (AS); and for the treatment of patients 12 years and older, tonsillitis/pharyngitis caused by Group A beta streptococci, as an alternative when beta lactam antibiotics are not appropriate.
The EU labeling includes Ketek's clinical efficacy against penicillin/or erythromycin resistant Streptococcus pneumoniae. When prescribing Ketek, consideration should be given to official guidance. In Phase III studies, the most commonly reported adverse events associated with Ketek were diarrhea, nausea, dizziness and vomiting.
"The world needs a new antibiotic that provides consistent, reliable first-line treatment of upper and lower respiratory tract infections, including those caused by drug resistant strains," said Thierry Soursac, MD, PhD, member of the management board and head of global commercial operations for Aventis, the maker and manufacturer of Ketek. "As the first ketolide antibiotic, Ketek represents an important therapy for physicians treating respiratory tract infections."
Ketek was launched first in October 2001 in Germany and has been approved in all EU and major Latin American markets. Ketek has over 4 million patient days of experience worldwide since its initial launch. In addition, the company filed a NDA in January 2002 for Ketek in Japan, the second largest antibiotic market worldwide.
The U.S. Food and Drug Administration (FDA) recently accepted for filing Aventis' complete response to the agency's June 1, 2001 approvable letter for Ketek (telithromycin) tablets (800 mg oral dose once daily) in the U.S for CAP, AECB and AS. The FDA has advised the company that a target action date is expected within six months. The filing includes data from a trial with more than 24,000 patients, which is the largest single comparative antibiotic trial ever conducted.