Avelox(R) Receives FDA Approval for Treatment of Uncomplicated Skin and Skin Structure Infections

- Respiratory Antibiotic Gains New Indication Based on Strong

Efficacy and Safety Data -



Apr 30, 2001, 01:00 ET from Bayer Corporation

    WEST HAVEN, Conn., April 30 /PRNewswire/ -- The U. S. Food and Drug
 Administration (FDA) has approved the use of Avelox(R) (moxifloxacin HCl), the
 second fluoroquinolone antibiotic from Bayer Corporation, as a once-daily
 treatment for uncomplicated skin and skin structure infections (uSSSI) due to
 Staphylococcus aureus and Streptococcus pyogenes. The approval, granted on
 April 27, 2001, six months after Bayer filed the application, was based on the
 FDA's review of a pivotal study supporting the use of Avelox in uSSSI and
 review of several safety studies completed by Bayer as part of the company's
 post-marketing commitments. Avelox, which is currently used to treat common
 adult community-acquired respiratory tract infections, has been used by over
 6 million patients worldwide since its approval in December 1999.
     "Avelox, with its once-daily dosing, favorable tissue penetration and
 gram-positive activity, offers physicians an alternative to agents
 traditionally used in treating uncomplicated skin and skin structure
 infections," said Deborah Church, M.D., Director, Anti-infective Medical
 Research, Bayer Corporation. "Physicians can prescribe Avelox for these skin
 infections with confidence."
 
     Studies and Findings
     A randomized, double-blind, controlled trial conducted in the US compared
 the safety and efficacy of Avelox (400 mg taken once daily for seven days) to
 a standard regimen of cephalexin HCl, a cephalosporin (500 mg taken three
 times daily for seven days), in the treatment of mild to moderate acute
 uncomplicated SSSIs. The study showed that Avelox was clinically and
 bacteriologically equivalent in efficacy to cephalexin in eradicating the
 pathogens most commonly found to cause uncomplicated skin infections
 (Staphylococcus aureus and Streptococcus pyogenes).
     The percentage of patients treated for uncomplicated abscesses was 30%;
 furuncles, 8%; cellulitis, 16%; impetigo, 20%; and other skin infections, 26%.
 Adjunctive procedures (incision and drainage or debridement) were performed on
 17% of the Avelox-treated patients and 14% of the cephalexin-treated patients.
 Clinical success rates in evaluable patients were 89% (108/122) for Avelox and
 91% (110/121) for cephalexin HCl.
     Results of the observational Avelox Clinical Experience Study (ACES), one
 of the largest antibiotic clinical studies ever conducted in the U.S., were
 submitted to the FDA to support the October 2000 submission for the uSSSI
 indication.  ACES, a study of more than 18,000 patients from more than 3,300
 centers in the US and Puerto Rico, was conducted to gather additional safety
 information on the use of Avelox. Specifically, ACES showed that there was no
 increased mortality associated with the use of Avelox in the treatment of
 adult community-acquired respiratory tract infections (RTIs), namely acute
 bacterial exacerbations of chronic bronchitis ABECB)(1), acute bacterial
 sinusitis(2), and community-acquired pneumonia of mild to moderate severity
 (CAP)(3).
 
     Important Safety Information
     Avelox is generally well tolerated. In clinical trials, the most common
 adverse events were nausea (8%), diarrhea (6%), dizziness (3%), headache (2%),
 abdominal pain (2%), and vomiting (2%).
     Avelox is contraindicated in persons with a history of hypersensitivity to
 Avelox or any quinolone antibiotic.  The safety and effectiveness of Avelox in
 pediatric patients, adolescents (less than 18 years of age), pregnant women,
 and lactating women have not been established.  Avelox has been shown to
 prolong the QT interval of the electrocardiogram in some patients. The drug
 should be avoided in patients with known prolongation of the QT interval,
 patients with uncorrected hypokalemia and patients receiving Class lA (e.g.,
 quinidine, procainamide) or Class lll (e.g., amiodarone, sotalol)
 antiarrhythmic agents, due to the lack of clinical experience with the drug in
 these patient populations. Pharmacokinetic studies between Avelox and other
 drugs that prolong the QT interval such as cisapride, erythromycin,
 antipsychotics, and tricyclic antidepressants have not been performed. An
 additive effect of Avelox and these drugs cannot be excluded; therefore,
 Avelox should be used with caution when given concurrently with these drugs.
     The effect of Avelox on patients with congenital prolongation of the QT
 interval has not been studied; however, it is expected that these individuals
 may be more susceptible to drug-induced QT prolongation. Because of limited
 clinical experience, Avelox should be used with caution in patients with
 ongoing proarrhythmic conditions, such as clinically significant bradycardia,
 or acute myocardial ischemia. As with all quinolones, Avelox should be used
 with caution in patients with known or suspected CNS disorders or in the
 presence of other risk factors that may predispose to seizures or lower the
 seizure threshold.
 
     More About Avelox
     Avelox, available in tablet form, is the first and only fluoroquinolone
 antibiotic indicated in the U.S. for five-day treatment of acute bacterial
 exacerbations of chronic bronchitis (ABECB)(4,5). Avelox is also approved for
 the 10-day treatment of acute bacterial sinusitis(6) and community acquired
 pneumonia of mild to moderate severity (CAP)(7). Avelox was the
 fastest-growing respiratory antibiotic in the US in the recent respiratory
 season, according to audited data from IMS HEALTH.*
     On November 2, 2000 Bayer submitted a new drug application (NDA) to the
 FDA for the intravenous (IV) form of Avelox for use in the treatment of common
 adult community-acquired respiratory tract infections(8). A decision from the
 FDA on the application is expected in 2001.
 
     About Bayer Corporation
     Best known for its flagship product, Bayer Aspirin, Bayer Corporation
 produces a broad range of health care, life sciences and chemical products
 that help diagnose and treat diseases, purify water, preserve local landmarks,
 protect crops, advance automobile safety and durability and improve people's
 lives.
     Headquartered in Pittsburgh, Bayer Corporation had sales of $10.1 billion
 in 2000 and is one of Fortune magazine's Most Admired Companies.  The company
 employs 23,200 people.  It is a member of the worldwide Bayer Group, a
 $29 billion international health care and chemicals group based in Leverkusen,
 Germany.  The Bayer Group (BAYG.DE) stock is a component of the DAX, and is
 listed on multiple foreign exchanges.  Bayer plans to list its stock on the
 New York Stock Exchange on September 26, 2001.
 
     1.  Caused by Streptococcus pneumoniae, Haemophilus influenzae,
         Haemophilus parainfluenzae, Klebsiella pneumoniae, Staphylococcus
         aureus, or Moraxella catarrhalis.
     2.  Caused by Streptococcus pneumoniae, Haemophilus influenzae, or
         Moraxella catarrhalis
     3.  Caused by Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma
         pneumoniae, Chlamydia pneumoniae, or Moraxella catarrhalis.
     4.  Caused by Streptococcus pneumoniae, Haemophilus influenzae,
         Haemophilus parainfluenzae, Klebsiella pneumoniae, Staphylococcus
         aureus, or Moraxella catarrhalis.
     5.  Data on file, Bayer Corporation, Pharmaceutical Division.
     6.  Caused by Streptococcus pneumoniae, Haemophilus influenzae, and
         Moraxella catarrhalis.
     7.  Caused by Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma
         pneumoniae, Chlamydia pneumoniae, or Moraxella catarrhalis.
         *NPA Plus 7, IMS HEALTH.
     8.  Among the IV indications being sought is CAP caused by Streptococcus
         pneumoniae (including penicillin-resistant strains), Haemophilus
         influenzae, Moraxella catarrhalis, Staphylococcus aureus, Klebsiella
         pneumonia, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Legionella
         pneumophila.
 
                     MAKE YOUR OPINION COUNT -- Click Here
                http://tbutton.prnewswire.com/prn/11690X74660654
 
 

SOURCE Bayer Corporation
    WEST HAVEN, Conn., April 30 /PRNewswire/ -- The U. S. Food and Drug
 Administration (FDA) has approved the use of Avelox(R) (moxifloxacin HCl), the
 second fluoroquinolone antibiotic from Bayer Corporation, as a once-daily
 treatment for uncomplicated skin and skin structure infections (uSSSI) due to
 Staphylococcus aureus and Streptococcus pyogenes. The approval, granted on
 April 27, 2001, six months after Bayer filed the application, was based on the
 FDA's review of a pivotal study supporting the use of Avelox in uSSSI and
 review of several safety studies completed by Bayer as part of the company's
 post-marketing commitments. Avelox, which is currently used to treat common
 adult community-acquired respiratory tract infections, has been used by over
 6 million patients worldwide since its approval in December 1999.
     "Avelox, with its once-daily dosing, favorable tissue penetration and
 gram-positive activity, offers physicians an alternative to agents
 traditionally used in treating uncomplicated skin and skin structure
 infections," said Deborah Church, M.D., Director, Anti-infective Medical
 Research, Bayer Corporation. "Physicians can prescribe Avelox for these skin
 infections with confidence."
 
     Studies and Findings
     A randomized, double-blind, controlled trial conducted in the US compared
 the safety and efficacy of Avelox (400 mg taken once daily for seven days) to
 a standard regimen of cephalexin HCl, a cephalosporin (500 mg taken three
 times daily for seven days), in the treatment of mild to moderate acute
 uncomplicated SSSIs. The study showed that Avelox was clinically and
 bacteriologically equivalent in efficacy to cephalexin in eradicating the
 pathogens most commonly found to cause uncomplicated skin infections
 (Staphylococcus aureus and Streptococcus pyogenes).
     The percentage of patients treated for uncomplicated abscesses was 30%;
 furuncles, 8%; cellulitis, 16%; impetigo, 20%; and other skin infections, 26%.
 Adjunctive procedures (incision and drainage or debridement) were performed on
 17% of the Avelox-treated patients and 14% of the cephalexin-treated patients.
 Clinical success rates in evaluable patients were 89% (108/122) for Avelox and
 91% (110/121) for cephalexin HCl.
     Results of the observational Avelox Clinical Experience Study (ACES), one
 of the largest antibiotic clinical studies ever conducted in the U.S., were
 submitted to the FDA to support the October 2000 submission for the uSSSI
 indication.  ACES, a study of more than 18,000 patients from more than 3,300
 centers in the US and Puerto Rico, was conducted to gather additional safety
 information on the use of Avelox. Specifically, ACES showed that there was no
 increased mortality associated with the use of Avelox in the treatment of
 adult community-acquired respiratory tract infections (RTIs), namely acute
 bacterial exacerbations of chronic bronchitis ABECB)(1), acute bacterial
 sinusitis(2), and community-acquired pneumonia of mild to moderate severity
 (CAP)(3).
 
     Important Safety Information
     Avelox is generally well tolerated. In clinical trials, the most common
 adverse events were nausea (8%), diarrhea (6%), dizziness (3%), headache (2%),
 abdominal pain (2%), and vomiting (2%).
     Avelox is contraindicated in persons with a history of hypersensitivity to
 Avelox or any quinolone antibiotic.  The safety and effectiveness of Avelox in
 pediatric patients, adolescents (less than 18 years of age), pregnant women,
 and lactating women have not been established.  Avelox has been shown to
 prolong the QT interval of the electrocardiogram in some patients. The drug
 should be avoided in patients with known prolongation of the QT interval,
 patients with uncorrected hypokalemia and patients receiving Class lA (e.g.,
 quinidine, procainamide) or Class lll (e.g., amiodarone, sotalol)
 antiarrhythmic agents, due to the lack of clinical experience with the drug in
 these patient populations. Pharmacokinetic studies between Avelox and other
 drugs that prolong the QT interval such as cisapride, erythromycin,
 antipsychotics, and tricyclic antidepressants have not been performed. An
 additive effect of Avelox and these drugs cannot be excluded; therefore,
 Avelox should be used with caution when given concurrently with these drugs.
     The effect of Avelox on patients with congenital prolongation of the QT
 interval has not been studied; however, it is expected that these individuals
 may be more susceptible to drug-induced QT prolongation. Because of limited
 clinical experience, Avelox should be used with caution in patients with
 ongoing proarrhythmic conditions, such as clinically significant bradycardia,
 or acute myocardial ischemia. As with all quinolones, Avelox should be used
 with caution in patients with known or suspected CNS disorders or in the
 presence of other risk factors that may predispose to seizures or lower the
 seizure threshold.
 
     More About Avelox
     Avelox, available in tablet form, is the first and only fluoroquinolone
 antibiotic indicated in the U.S. for five-day treatment of acute bacterial
 exacerbations of chronic bronchitis (ABECB)(4,5). Avelox is also approved for
 the 10-day treatment of acute bacterial sinusitis(6) and community acquired
 pneumonia of mild to moderate severity (CAP)(7). Avelox was the
 fastest-growing respiratory antibiotic in the US in the recent respiratory
 season, according to audited data from IMS HEALTH.*
     On November 2, 2000 Bayer submitted a new drug application (NDA) to the
 FDA for the intravenous (IV) form of Avelox for use in the treatment of common
 adult community-acquired respiratory tract infections(8). A decision from the
 FDA on the application is expected in 2001.
 
     About Bayer Corporation
     Best known for its flagship product, Bayer Aspirin, Bayer Corporation
 produces a broad range of health care, life sciences and chemical products
 that help diagnose and treat diseases, purify water, preserve local landmarks,
 protect crops, advance automobile safety and durability and improve people's
 lives.
     Headquartered in Pittsburgh, Bayer Corporation had sales of $10.1 billion
 in 2000 and is one of Fortune magazine's Most Admired Companies.  The company
 employs 23,200 people.  It is a member of the worldwide Bayer Group, a
 $29 billion international health care and chemicals group based in Leverkusen,
 Germany.  The Bayer Group (BAYG.DE) stock is a component of the DAX, and is
 listed on multiple foreign exchanges.  Bayer plans to list its stock on the
 New York Stock Exchange on September 26, 2001.
 
     1.  Caused by Streptococcus pneumoniae, Haemophilus influenzae,
         Haemophilus parainfluenzae, Klebsiella pneumoniae, Staphylococcus
         aureus, or Moraxella catarrhalis.
     2.  Caused by Streptococcus pneumoniae, Haemophilus influenzae, or
         Moraxella catarrhalis
     3.  Caused by Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma
         pneumoniae, Chlamydia pneumoniae, or Moraxella catarrhalis.
     4.  Caused by Streptococcus pneumoniae, Haemophilus influenzae,
         Haemophilus parainfluenzae, Klebsiella pneumoniae, Staphylococcus
         aureus, or Moraxella catarrhalis.
     5.  Data on file, Bayer Corporation, Pharmaceutical Division.
     6.  Caused by Streptococcus pneumoniae, Haemophilus influenzae, and
         Moraxella catarrhalis.
     7.  Caused by Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma
         pneumoniae, Chlamydia pneumoniae, or Moraxella catarrhalis.
         *NPA Plus 7, IMS HEALTH.
     8.  Among the IV indications being sought is CAP caused by Streptococcus
         pneumoniae (including penicillin-resistant strains), Haemophilus
         influenzae, Moraxella catarrhalis, Staphylococcus aureus, Klebsiella
         pneumonia, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Legionella
         pneumophila.
 
                     MAKE YOUR OPINION COUNT -- Click Here
                http://tbutton.prnewswire.com/prn/11690X74660654
 
 SOURCE  Bayer Corporation