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FDA Gives Approvable Letter For Ketek (Telithromycin) Tablets For Treatment Of Community-Acquired Respiratory Tract Infections
STRASBOURG, FRANCE -- January 27, 2003 -- Aventis (NYSE: AVE) announced today that it received an approvable letter from the U.S. Food and Drug Administration (FDA) for KetekŪ (telithromycin) tablets for the treatment of acute exacerbations of chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia.
In the approvable letter FDA has requested that Aventis provide additional analyses and information prior to marketing approval. The Agency has not required additional clinical studies.
"The Advisory Committee and the FDA have recognized Ketek as an innovative agent to treat community-acquired respiratory tract infections," said Frank Douglas, MD, Executive Vice President and Chief Scientific Officer of Drug Innovation & Approval (DI&A) at Aventis. "Aventis is confident that the abundant data submitted clearly support the safety and efficacy of Ketek and we will respond expeditiously."
The FDA's decision follows a positive recommendation from the Anti-Infective Drugs Advisory Committee (AIDAC) on January 8, 2003. Ketek was first launched in October 2001 in Germany and has been approved in all EU and major Latin American markets.
About Ketek
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 Streptococcus pneumoniae pathogens. In clinical trials, the most commonly reported side effects (> or equal to 2 percent) were diarrhea, nausea and vomiting.
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, invested euro 3 billion in research and development and employed approximately 75,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. For more information, please visit: http://www.aventis.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
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