FDA extends Biaxin label to include CAP

The US Food and Drug Administration has approved Abbott Laboratories'new seven-day indication for extended-release Biaxin (clarithromycin) for the treatment of mild-to-moderate community-acquired pneumonia in adults caused by Haemophilis influenzae, H parainfluenzae, Moraxella catarrhalis, Strepstococcus pneumoniae, Chlamydia pneumoniae and Mycoplasma pneumoniae. The drug is currently approved for the treatment of acute bacterial exacerbation of chronic bronchitis and acute maxillary sinusitis (Marketletter March 13, 2000).

During a recent Phase III trial, 1,000mg of Biaxin was compared to 500mg of the leading quinolone antibiotic, Johnson & Johnson's Levaquin (levofloxacin), both administered 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.

Results of the study demonstrated that a clinical cure rate was achieved by 88% of patients treated with Biaxin, compared to 86% of those given Levaquin. Adverse events reported with both drugs were similar, and included diarrhea, headache and nausea. However, a statistically-significant difference was noted in abnormal taste, at 13% of Biaxin patients compared to 1% of Levoquin patients.