STRASBOURG -- Aventis announced today that it received an approvable letter from the U.S. Food and Drug Administration (FDA) for KETEK(R) (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 and 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.
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.
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.