Telavancin positive Phase III data
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Theravance announces positive results from its pivotal Phase III ATLAS I and ATLAS II trials to assess the safety and efficacy of telavancin, an injectable lipoglycopeptide antibiotic for treatment of complicated skin and skin structure infections. The multi-center, multinational, double-blind studies enrolled 1,867 patients, 719 of whom were infected with methicillin-resistant Staphylococcus aureus. Both studies reached their primary endpoints of non-inferiority and achieved a numerically better clinical cure rate than vancomycin. The company announced Phase II results at the Interscience Conference on Antimicrobial Agents and Chemotherapy last December 1(Pharmaceutical Approvals Monthly January 2006, p. 36)...