FDA approves Abbott's Biaxin® XL (clarithromycin extended-release tablet)for community-acquired pneumonia

August 06, 2001

ABBOTT PARK, Ill., Aug. 6, 2001 - Abbott Laboratories announced today it has received U.S. Food and Drug Administration (FDA) approval of a new seven-day indication for Biaxin(R) XL (clarithromycin extended-release tablets) for the treatment of mild-to-moderate community-acquired pneumonia (CAP) in adults. Biaxin XL is the once-daily formulation of Abbott Laboratories' widely prescribed, advanced-generation macrolide antibiotic, Biaxin (R) (clarithromycin) tablets. The study used in the approval of the new indication demonstrates that the clinical cure rate achieved with Biaxin XL is comparable to that achieved with a leading quinolone antibiotic, Levaquin (R) (levofloxacin), in the treatment of CAP.

The newly approved indication for Biaxin XL is for the treatment of mild-to-moderate CAP caused by Haemophilis influenzae, Haemophilis parainfluenzae, Moraxella catarrhalis, Streptococcus pneumoniae, Chlamydia pneumoniae (TWAR), and Mycoplasma pneumoniae.

"The similar efficacy of Biaxin XL in the clinical trial against a leading quinolone shows that Biaxin XL will provide a valuable treatment option for physicians in treating CAP," said Lee R. Weiss, M.D., F.A.C.E.P., clinical associate professor, Departments of Medicine and Emergency Medicine, Ohio State University School of Medicine, Columbus, Ohio. "It's important to have a number of treatment options to select from, however, health care providers need to ensure they are prescribing an antibiotic that provides an appropriate spectrum of coverage for CAP. This also means recognizing when to reserve some antibiotics for patients with more serious infections."

Biaxin XL Clinical Trial in CAP
Biaxin XL and Levaquin were compared in a double-blind, parallel-group, multicenter study in 299 ambulatory patients with CAP. Patients were randomized to receive either 1,000 mg of Biaxin XL (two 500 mg tablets) once-a-day for seven days, or 500 mg of Levaquin (two 250 mg capsules) once-a-day for seven days. Efficacy was measured at the test-for-cure visit, which occurred 14 to 21 days after the last dose was taken.

According to study results, a clinical cure rate was achieved by 88 percent (113/128) of patients taking Biaxin XL, compared to 86 percent (107/124) of patients taking Levaquin. A clinical cure diagnosis was based on resolution or improvement of signs and symptoms associated with CAP, without the need for additional antimicrobial therapy. Both treatment regimens were comparable in resolving and improving clinical signs and symptoms of pneumonia, and resolving or improving pneumonia as measured by a chest x-ray.

The most frequently reported adverse events with Biaxin XL and Levaquin tablets were diarrhea (6 percent and 6 percent, respectively), headache (3 percent and 4 percent, respectively), and nausea (3 percent and 3 percent, respectively). A statistically significant difference was noted in abnormal taste, which was reported by more patients taking Biaxin XL than Levaquin (13 percent and <1 percent, respectively).

"Abbott is pleased to have FDA approval of this important indication for Biaxin XL," said Dave Goffredo, president, Pharmaceutical Products Division at Abbott Laboratories. "We are committed to meeting the needs of patients and physicians and believe that Biaxin XL will prove to be an important treatment option for physicians who treat the three million Americans affected by CAP each year."

Biaxin XL tablets are also indicated for mild-to-moderate infections in adults with acute bacterial exacerbation of chronic bronchitis (AECB) caused by Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae, and acute maxillary sinusitis (AMS) caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. The efficacy and safety of Biaxin XL in treating other infections for which other formulations of Biaxin are approved have not been established.

Biaxin XL tablets are contraindicated in patients with a known hypersensitivity to clarithromycin or any macrolide antibiotic. Concomitant administration with Propulsid® (cisapride), Orap® (pimozide), or Seldane® (terfenadine) is contraindicated due to the potential for cardiac arrhythmias. Biaxin XL tablets should not be used in pregnant women except in circumstances for which no alternative therapy is appropriate. Biaxin XL tablets may elevate digoxin serum concentration. Serum digoxin levels should be carefully monitored while digoxin and clarithromycin are taken concomitantly. The dose of clarithromycin should be halved or the dosing interval doubled in patients with severe renal impairment (CrCl<30ml> CAP is the most common type of pneumonia, which is an infection or inflammation of the lungs. Affecting two to three million Americans each year, CAP results in approximately 10 million physician visits annually. The most common symptoms of CAP include malaise, shaking chills, chest pain, weakness, fever, and a cough that produces rust or greenish-colored mucus. According to recent treatment guidelines for CAP issued by a working group from the Centers for Disease Control and Prevention (CDC), macrolides, including clarithromycin, are recommended as first-line treatment options for outpatients with CAP.
Abbott Laboratories has a long history of leadership in anti-infectives dating back to the 1930s. Abbott was one of the five pioneers in the United States to start commercial production of penicillin. Years later, in conjunction with the research efforts of two other pharmaceutical companies, Abbott developed an early macrolide antibiotic. In addition to Biaxin XL, Abbott also markets a cephalosporin antibiotic and recently signed a global licensing agreement with Wakunaga Pharmaceutical Co., Ltd., of Osaka, Japan, to develop and market two investigational anti-infective compounds. Abbott's commitment continues today with extensive research to discover and develop new compounds in this area.

Abbott Laboratories is a global, diversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals, nutritionals and medical products, including devices and diagnostics. The company employs approximately 70,000 people and markets its products in more than 130 countries. In 2000, the company's sales and net earnings were $13.7 billion and $2.8 billion, respectively, with diluted earnings per share of $1.78.

Abbott's news releases and other information, including full prescribing information for Biaxin and Biaxin XL, can be found on the company's Web site at www.abbott.com.

Additional Contact:
Melissa Brotz
847- 935-3456

Porter Novelli

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