TWEST HAVEN, CT -- May 19, 2004 --
The United States Food and Drug Administration (FDA) has approved a supplemental new drug application for Avelox® (moxifloxacin HCI) Tablets and I.V. for the treatment of community acquired pneumonia (CAP) caused by multi-drug resistant Streptococcus pneumoniae (MDRSP*). Avelox is the first antibiotic available in both tablet and I.V. forms approved to treat CAP caused by these strains, which are resistant to the antibiotics most commonly used to treat pneumonia.
Two to three million cases of CAP are reported annually in the United States, resulting in 10 million physician visits, 500,000 hospitalizations and 45,000 deaths each year.(1) Currently, CAP is the sixth leading cause of death in the United States.(2) While the majority of CAP cases are caused by S. pneumoniae,(3) the cases of this bacteria becoming resistant to antibiotics are rising. Common antibiotics used to treat CAP such as azithromycin and penicillin have S. pneumoniae resistance rates of 29% and 25%, respectively, and resistance is continuing to rise.(4)
Avelox demonstrated excellent clinical and bacteriological success against strains resistant to two to five commonly used antibiotics, including macrolides such as clarithromycin and azithromycin, penicillin, second-generation cepholosporins such as cefuroxime, trimethoprim- sulfamethoxazole, and tetracyclines with eradication rates of 93% to 100%.
"The rise of resistance among S. pneumoniae is complicating the treatment of pneumonia worldwide," said Paul MacCarthy, M.D., Vice President, Medical Science, Bayer Pharmaceuticals Corporation. "Antibiotic failure due to resistance can result in prolonged suffering for patients, time lost from work, increased healthcare costs, and serious illnesses that can lead to increased mortality. With approval to treat MDRSP in tablet and I.V. forms, Avelox will be an important treatment option for CAP especially during this time of emerging resistance to conventional therapies."
"The approval of Avelox in another critical indication (MDRSP) may allow us to grow our market share further and expand our strong anti-infective franchise with development programs that bring other critical indications on line over the life span of the drug," said Colin Foster, President and CEO, Bayer Pharmaceuticals Corporation.