Theravance Announces Posting of Briefing Documents for FDA Anti-Infective Drugs Advisory Committee Meeting on Telavancin
Monday November 17, 9:23 am ET
SOUTH SAN FRANCISCO, CA--(MARKET WIRE)--Nov 17, 2008 -- Theravance, Inc. (NasdaqGM:THRX - News) today announced that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the November 19, 2008 Anti-Infective Drugs Advisory Committee (AIDAC) meeting. The AIDAC will be asked to review and discuss Theravance's New Drug Application (NDA) for telavancin, a novel, bactericidal, once-daily injectable investigational antibiotic, for the proposed indication to treat complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA).
The Theravance Briefing Document and the FDA Briefing Document are now available at fda.gov.
About ATLAS 1 and ATLAS 2 Clinical Studies
The telavancin NDA is based on data from two large, multinational, double-blind, randomized Phase 3 clinical studies designed to compare the efficacy and safety of telavancin (10 mg/kg IV once daily) versus vancomycin (1 gm IV q 12hr) in the treatment of cSSSI caused by Gram-positive bacteria. In both of these studies (ATLAS 1 and ATLAS 2), which enrolled and treated 1,867 patients in total, 719 of whom had infections with MRSA, telavancin achieved its primary endpoint of non-inferiority relative to the standard of care, vancomycin. The safety profile of telavancin in these studies was compatible with treatment of patients with serious infections. |
