Aventis reported that the Anti-Infective Drugs Advisory Committee (AIDAC) of the U.S. Food and Drug Administration (FDA) voted to recommend approval of Ketek (telithromycin) tablets (800 mg oral dose once daily) for the treatment of acute exacerbations of chronic bronchitis (once a day for five days), for the treatment of acute sinusitis (once a day for five days) and for the treatment of community-acquired pneumonia (once a day for seven to 10 days).
The Committee also voted by majority that the safety and efficacy data presented supported the use of Ketek for the treatment of penicillin- and macrolide-resistant strains of S. pneumoniae in community-acquired pneumonia and acute sinusitis.
The recommendations of the Advisory Committee are subject to discussion with the FDA to secure final labeling prior to the US market introduction of Ketek.
"The positive recommendations and comments are a vote of confidence for Ketek and the company was commended for its commitment to bringing innovative drugs to patients and physicians. The Committee's decision was supported by the unprecedented body of global clinical trial and post-marketing data," said Frank Douglas, MD, executive vice president and chief scientific officer of Drug Innovation & Approval (DI&A) at Aventis. "We will continue to work with the FDA to bring this important new treatment to the healthcare community," he added.
Ketek is the first in a new class of antibiotics known as ketolides that was designed to deliver an optimal spectrum of activity for the first line treatment of upper and lower respiratory tract infections, including those caused by resistant pathogens – with less propensity to induce resistance and a short treatment regimen.
Safety and efficacy data evaluated by the Advisory Committee included Phase III studies involving 4,472 patients treated with Ketek, a controlled trial involving over 24,000 patients in a “usual-care” setting, where approximately 12,000 were treated with Ketek (including patients at risk for complications), and post-marketing experience from more than 1.5 million exposures to Ketek in the EU and Latin America. Ketek was launched first in October 2001 in Germany and has been approved in all EU and major Latin American markets. In addition, the company filed a NDA in January 2002 for Ketek in Japan, the second largest antibiotic market worldwide. In clinical trials, the most commonly reported side effects (2 percent) were diarrhea, nausea and vomiting.