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WEST HAVEN, Conn. -- 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 3 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 percent to 100 percent.
"The rise of resistance among S. pneumoniae is complicating the treatment
of pneumonia worldwide," said Paul MacCarthy, MD, vice president of medical
science for 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 of
Bayer Pharmaceuticals Corporation.
Avelox is approved to treat: Community Acquired Pneumonia (CAP) caused by
Streptococcus pneumoniae (including multi-drug resistant strains*) Haemophilus
influenzae, Moraxella catarrhalis, Staphylococcus aureus, Klebsiella
pneumoniae, Mycoplasma pneumoniae, or Chlamydia pneumoniae; Acute Bacterial
Exacerbations of Chronic Bronchitis (ABECB) caused by Streptococcus
pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella
pneumoniae, Staphylococcus aureus, or Moraxella catarrhalis; Acute Bacterial
Sinusitis (ABS) caused by Streptococcus pneumoniae, Haemophilus influenzae, or
Moraxella catarrhalis; and Uncomplicated Skin and Skin Structure Infections
(uSSSI) caused by Staphylococcus aureus or Streptococcus pyogenes.
*MDRSP, Multi-drug resistant Streptococcus pneumoniae, includes isolates
previously known as PRSP (penicillin-resistant Streptococcus pneumoniae), and
are strains resistant to two or more of the following antibiotic classes:
penicillin (MIC greater than or equal to 2 mcg/mL), second generation
cephalosporins, e.g. cefuroxime, macrolides, tetracyclines and trimethoprim/
(1) Bartlett, J. et al. Clin Infect Dis 2000; 31:347-82
(2) Bartlett, J. et al. Clin Infect Dis 2000; 31:347-82
(3) Whitney, C. et al. N Engl J Med 2000; 343:1917-24.
(4) Jacobs et al. The Alexander Project 1998-2000. J Antimicrob Chemother.
Source: Bayer Pharmaceuticals Corporation