FDA Approves Avelox for Community-Acquired Pneumonia Due to Multi-Drug Resistant Streptococcus pneumoniae

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/

sulfamethoxazole.

References:

(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.

2003;52:229-46

Source: Bayer Pharmaceuticals Corporation