FDA panel may discuss telavancin

Theravance (THRX) said FDA's Anti-Infective Drugs Advisory Committee may soon meet to review an NDA for telavancin to treat complicated skin and skin structure infections (cSSSIs) caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Under the FDA Amendments Act of 2007 (FDAAA) passed in September, an advisory committee review is required for new chemical entities progressing toward approval, unless FDA can state why a panel review is not necessary. Telavancin, an injectable lipoglycopeptide antibiotic, is a new chemical entity in a new chemical class.

THRX said it has not submitted new data to FDA since receiving an approvable letter for telavancin in October. At that time, THRX and partner Astellas (Tokyo:4503) said FDA requested resolution of cGMP compliance issues unrelated to the compound at a third-party manufacturer, and submission of revised labeling or re-analyses of clinical data or additional clinical data. The companies did not believe new clinical trials would be needed ( See BioCentury Extra, Monday, Oct. 22, 2007). ...