Theravance's telvancin meeting with FDA draws closer

US drugmaker Theravance has been told by the Food and Drug Administration that its Anti-Infective Drugs Advisory Committee may soon meet to review the New Drug Application for telavancin, a novel, bactericidal, once-daily injectable antibiotic proposed to treat complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus.

Earlier this year, the FDA issued an "approvable letter" for telavancin, which is being co-developed with Japanese drug major Astellas (Marketletter October 29). The letter indicated that the agent's approval is subject to the resolution of current Good Manufacturing Practices compliance issues, not specifically related to telavancin, but at a third-party manufacturer, as well as the submission of revised labeling or re-analyses of study data or additional clinical work. At the time, the companies stated their belief that no additional studies were needed to respond to the letter.