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Nosocomial Pneumonia Indication Approved For Levaquin (Levofloxacin)

RARITAN, NJ -- November 5, 2002 -- The U.S. Food and Drug Administration (FDA) has approved Levaquin® (levofloxacin) Tablets/Injection and Levaquin(R) (levofloxacin in 5% dextrose) Injection 750mg for the treatment of nosocomial (hospital-acquired) pneumonia. With this indication, Levaquin, a fluoroquinolone anti-infective, is now approved by the FDA to treat a form of pneumonia that affects approximately 300,000 patients in the United States annually.

Levaquin is marketed by Ortho-McNeil Pharmaceutical, Inc.

Nosocomial pneumonia is the second most common hospital-acquired infection in the United States and is associated with mortality rates of 30 to 33 percent. In the United States, nosocomial pneumonia results in average hospital costs of $2 billion per year and increases hospital stays by an average of seven to nine days per patient. It occurs more frequently in people aged 65 and older; those with underlying disease, immunosuppression, and cardiopulmonary disease; and those who have had thoraco-abdominal surgery. Signs and symptoms typically appear 48 to 72 hours after hospital admission and may include fever, worsening lung function and infected sputum from the respiratory tract. It can lead to respiratory failure and a requirement for mechanical ventilation.

"This indication further adds to the clinical utility of Levaquin," said Joseph Lynch, III, M.D., professor of medicine, Division of Pulmonary and Critical Care Medicine, University of Michigan School of Medicine, Ann Arbor. "The ability to increase the dose of Levaquin to 750mg from 500mg without major change in safety or side effects is a benefit when treating the more serious pathogens associated with nosocomial pneumonia, like Pseudomonas aeruginosa."

The new indication is based on data from a pivotal, multi-center, randomized, open-label study with 438 patients comparing intravenous Levaquin (750mg once daily) followed by oral Levaquin (750mg once daily) for a total of 7-15 days to intravenous PRIMAXIN(R)(1) (imipenem/cilastatin) (500-1000mg dosed every 6-8 hours) followed by oral CIPRO(R)(2) (ciprofloxacin) (750mg dosed every 12 hours daily) for a total of 7-15 days. Data provided to the FDA demonstrated that Levaquin was as effective as the comparator treatment used in this study. Levaquin is indicated for nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a confirmed or suspected pathogen, combination therapy with an anti-pseudomonal beta-lactam anti-infective is recommended.

As the treatment course for patients with nosocomial pneumonia begins in the hospital and may extend beyond discharge, the comparable bioavailability of Levaquin injection and tablets allows for the use of the same dose for both intravenous and oral administration, affording physicians and patients seamless transition from inpatient to outpatient treatment.

In the United States, Levaquin is indicated for a wide range of infections of the respiratory and urinary tracts as well as skin and skin structure infections. More than 250 million courses of Levaquin have been prescribed worldwide since 1993.

The safety and efficacy of levofloxacin in pediatric patients, adolescents (under 18), pregnant women and nursing mothers have not been established.

Levofloxacin is contraindicated in persons with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents or any other components of this product. Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones, including levofloxacin. These reactions often occur following the first dose. The drug should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.

Antacids containing magnesium or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc, or Videx®(3) (didanosine) chewable/buffered tablets or the pediatric powder for oral solution should be taken at least two hours before or two hours after levofloxacin administration.

For more information on warnings, precautions, and additional adverse reactions that may occur, regardless of drug relationship, please see the full U.S. Prescribing Information available upon request or at ttp://www.levaquin.com or http://www.ortho-mcneil.com .

Levaquin has been marketed in the United States by Ortho-McNeil since January 1997. Ortho-McNeil, a Johnson & Johnson company, is based in Raritan, NJ. The company markets pharmaceutical products in several therapeutic categories including infectious diseases, women's health, central nervous system and urology.

(1) Primaxin is a registered trademark of Merck & Company, Inc.
(2) Cipro is a registered trademark of Bayer AG
(3) Videx is a registered trademark of Bristol-Myers Squibb Company


SOURCE: Ortho-McNeil Pharmaceutical, Inc.

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