First Approval For Glaxo Wellcome's Grepafloxacin

Glaxo Wellcome has received approval from the German regulatoryauthorities, the BfArM, to market grepafloxacin, its broad-spectrum fluoroquinolone antibiotic for the treatment of respiratory tract infections. This is GW's first approval for the drug.

Grepafloxacin has been approved for the once-daily treatment of community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis and a number of sexually transmitted diseases. The drug, which was licensed to GW by Otsuka Pharmaceutical of Japan for Europe and the USA, is effective against both Gram-positive and Gram-negative bacteria and also has activity against the beta-lactam- and macrolide-resistant strains of Streptococcus pneumoniae and Hemophilus influenzae.

In one Phase III study, 656 patients with acute bacterial exacerbations of chronic bronchitis received seven-10 days of oral therapy with grepafloxacin 400mg once daily, grepafloxacin 600mg once daily or amoxicillin 500mg three times daily. Grepafloxacin was found to be as clinically effective as amoxicillin in treating the disease, but was significantly more microbiologically effective.