Avelox wins supplemental approval for community acquired pneumonia

Avelox wins supplemental approval for community acquired pneumonia

WEST HAVEN, CONN., March 4, 2003 -- The FDA has approved a supplemental new drug application for Avelox (moxifloxacin HCl) Tablets/I.V. as a treatment for community-acquired pneumonia (CAP) due to penicillin-resistant Streptococcus pneumoniae (PRSP).

"Avelox, a highly active agent in the fluoroquinolone class, is now an important option in treating penicillin-resistant S. pneumoniae," said Dr. Shurjeel Choudhri, Director, Senior Clinical Research Physician, Bayer Pharmaceuticals Corporation. "A key principal of proper antibiotic use is choosing an agent with excellent activity which may help reduce the development of resistance and maintain efficacy. Avelox has been shown in clinical studies to demonstrate high activity in vitro and excellent clinical success against S. pneumoniae -- important because this organism's resistance is a worldwide public health concern."

Data provided to the FDA showed that Avelox therapy was effective in each of the 21 cases of pneumonia caused by penicillin-resistant Streptococcus pneumoniae. The clinical and bacteriological efficacy of Avelox in the treatment of Streptococcus pneumoniae was evaluated in nine clinical studies, which totaled 244 Avelox treated patients with CAP due to S. pneumoniae.

About 25 to 35 percent of S. pneumoniae isolates in the United States are currently resistant or intermediately resistant to penicillin, according to the IDSA.(1) The National Institutes of Health (NIH) estimate there are approximately four million cases of community-acquired pneumonia in the United States each year,(2) and, according to the Centers for Disease Control and Prevention (CDC), Streptococcus pneumoniae infections cause up to 135,000 hospitalizations.(3)

Avelox has demonstrated excellent antibacterial effect on all major bacterial causes of respiratory tract infection. The agent was first approved in 1999 in both Europe and the United States. To date, there have been nearly 17 million Avelox patient uses for its various indications in more than 80 countries worldwide.

Avelox (moxifloxacin HCl) Tablets and I.V. are indicated for acute bacterial exacerbation of chronic bronchitis (ABECB), acute bacterial sinusitis, community-acquired pneumonia (CAP), and uncomplicated skin and skin structure infections (uSSSI), caused by susceptible strains of indicated organisms.(4)

Avelox is a prescription medication that is generally well-tolerated. The most common side effects, which are usually mild, include nausea, diarrhea, and dizziness. You should be careful about driving or operating machinery until you are sure Avelox is not causing dizziness.

Patients should not take Avelox if they have ever had an allergic reaction to Avelox or any of the other group of antibiotics known as "quinolones," such as ciprofloxacin or levofloxacin. They should avoid taking Avelox if they have been diagnosed with an abnormal heartbeat such as an arrhythmia or are using certain medications used to treat an abnormal heartbeat. These include quinidine, procainamide, amiodarone, and sotalol.

Avelox is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown. Avelox is not recommended for children under the age of 18 years.

For Avelox prescribing information and indicated organisms, log on to www.AveloxUSA.com or call Bayer Clinical Communications at 800-288-8371.

(1) Bartlett J, Dowell S, Mandell L, File T, Musher D, and Fine M. Guidelines from the Infectious Disease Society of America: practice guidelines for the management of community-acquired pneumonia in adults. Clinical Infectious Disease 2000;31:347-82

(2) National Institutes of Health (NIH).  www.nlm.nih.gov/medlineplus/ency/article/000145.htm

(3) Centers for Disease Control and Prevention (CDC). www.cdc.gov/ncidod/dbmd/diseaseinfo/drugresisstreppneum_t.htm [Online]

(4) Avelox is approved for use in the treatment of Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Staphylococcus aureus, or Moraxella catarrhalis; Acute Bacterial Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis; Community-acquired Pneumonia caused by Streptococcus pneumoniae (including penicillin-resistant strains, MIC value for penicillin greater than or equal to 2ug/mL), Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydia pneumoniae; and Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus or Streptococcus pyogenes.

Source: Bayer Pharmaceuticals Corporation www.aveloxusa.com

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