Theravance telavancin pivotal enrollment complete
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Theravance wraps up accrual in initial Phase III program evaluating its lipoglycopeptide antibiotic telavancin for use in complicated skin and skin structure infections due to Gram-positive bacteria, the San Francisco-based firm says May 16. "We have enrolled more than 1,800 patients overall and expect to have more than one-third with confirmed [methicillin-resistant Staphylococcus aureus] infections at baseline," the company says, noting that the design allows for detection of potential superiority over vancomycin, the standard treatment for MRSA infections. Phase II telavancin data were presented at the Interscience Conference on Antimicrobial Agents & Chemotherapy in Washington, D.C. in December. Cure rates for MRSA were similar for telavancin and standard care (1Pharmaceutical Approvals Monthly January 2006, p. 36)...