BiotechTracker - Ketek Data at ATS Justify U.S. Approval
May 20, 2003 Data from two investigations presented at the American Thoracic Society (ATS) meeting support the clinical utility of Aventis’s (NYSE: AVE) Ketek (telithromycin) in the management of both community-acquired pneumonia (CAP) and acute exacerbations of chronic bronchitis (AECB). Ketek was approved in Europe in July 2001, making it the first Ketolide antibiotic on the market in Europe. It should be the first in the U.S. as well. Ketek’s ability to treat drug resistant pathogens, which are arising ever more frequently, should make it a popular choice in U.S. clinics.  The road to U.S. approval has been slow. The FDA’s Anti-Infective Drugs Advisory Committee has recommended approval for the treatment of specific clinical scenarios in respiratory infection: CAP, AECB, acute sinus infections (AS), and pneumonia and sinus infections specifically caused by Streptococcus pneumoniae that are resistant to penicillins and macrolides. In late January this year, Aventis received an approvable letter from the FDA for Ketek tablets for the treatment of CAP, AECB, and AS. Aventis is to provide additional analyses and information, but not data from newly initiated trials, to the FDA prior to marketing approval. Aventis is currently preparing its response, which we view as overwhelmingly likely to be successful. U.S. launch is expected in the third quarter of this year.  In the investigations at ATS, once-daily Ketek for five or seven days for CAP, and for five days in high-risk AECB, was as clinically active as more frequently taken standard antibiotic regimens for 10 days. Two meta-analyses – the first an analysis of three AECB studies, and the second an analysis of twelve CAP and AECB studies – were presented, as were data demonstrating the cost-effectiveness of Ketek compared to clarithromycin.  For AECB in the first study, three randomized, double-blind, comparator-controlled clinical trials provided data for meta-analysis. Ketek 800 mg once daily for five days (n=615) was pitted against amoxicillin-clavulanic acid 500/125 mg three times daily for 10 days (n=160), cefuroxime axetil 500 mg twice daily for 10 days (n=191), and clarithromycin 500 mg twice daily for 10 days (n=282). Of evaluable patients 65 years and older or at increased risk due to underlying comorbidities such as severe pulmonary obstruction, clinical and bacteriologic outcomes were assessed 17-21 days following treatment. Returns to a baseline pre-infection state or improvement in current infection for Ketek recipients was 87.1% (413/480) versus 85.6% for pooled comparators (416/485).  For CAP in the second study, meta-analytic data were mined from six randomized, double-blind, randomized, comparator-controlled studies and four studies without a comparator. Patients with CAP (n=2,432) were treated with Ketek 800 mg once daily for seven to 10 days, amoxicillin 1,000 mg three times daily for 10 days, clarithromycin 500 mg twice a day for 10 days, or trovafloxacin 200 mg once daily for seven to 10 days. For ACEB in the second study, meta-analytic data were mined from six randomized, double-blind, randomized, comparator-controlled studies and four studies without a comparator. Patients with AECB (n=1,245) were treated with Ketek 800 mg once daily for five days, amoxicillin-clavulanic acid 500/125 mg three times daily for 10 days, or cefuroxime axetil 500 mg twice daily for 10 days.  Overall, in the second study, returns to a baseline pre-infection state or improvement in current infection for Ketek recipients was 90.5% (1,886/2,085) versus 87.5% for pooled comparators (814/930). For high risk patients (including age at least 65 years or with more severe disease), the analogous success rates were for 87.8% (807/919) for Ketek recipients and 83.4% for recipients of drugs that were the pooled comparators.  Analysis of cost data from a 575 CAP-patient program showed that the mean per patient cost of CAP-related care was $151 and $385 for patients treated with Ketek for five or seven days, respectively, versus $569 for patients treated with clarithromycin for 10 days.
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