my personal edition > respiratory infections > news


  E-Mail this DGNews to a colleague

DGNews

Advisory Panel Recommends FDA Approval Of Ketek (Telithromycin) For Treatment Of Respiratory Tract Infections

First Antibiotic In New Class

BRIDGEWATER, NJ -- January 9, 2003 -- Aventis announced 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 ten 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 U.S. 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. Ketek was designed to deliver an optimal spectrum of activity, with a short treatment duration, specifically for upper and lower respiratory tract infections, including those caused by drug-resistant S. pneumoniae pathogens.

In clinical trials, the most commonly reported side effects (greater than or equal to 2 percent) were diarrhea, nausea and vomiting.

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.

About Aventis
Aventis is dedicated to improving life by treating and preventing human disease through the discovery and development of innovative prescription drugs for important therapeutic areas as well as human vaccines. In 2001, Aventis generated sales of euro 17.7 billion ($15.8 billion), invested euro 3 billion ($2.7 billion) in research and development and employed approximately 75,000 people in its core business. Aventis corporate headquarters is in Strasbourg, France. The company's prescription drugs business is conducted in the U.S. by Aventis Pharmaceuticals Inc., which is headquartered in Bridgewater, New Jersey. Aventis was recently named one of the top companies to work for by Working Mother magazine. For more information about Aventis in the U.S., please visit: http://www.aventis-us.com .

To receive a copy of this release or any recent release, visit the Aventis Web site at http://www.aventis-us.com .

Statements in this news release other than historical information are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission.


SOURCE: Aventis

E-Mail this DGNews to a colleague

To print, use this version