US FDA "approvable letter" for telavancin

The US Food and Drug Administration has issued an "approvable letter" for telavancin, a novel bactericidal, once-daily injectable antibiotic discovered by USA-based Theravance, and which is being co-developed with Japanese drug major Astellas, for the treatment of complicated skin and skin structure infections caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus.

The letter indicates that telavancin'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. The companies believe that no additional studies will need to be initiated to respond to the letter.

Rick Winningham, chief executive of Theravance, said: "we will work with the FDA to resolve the outstanding issues and to ensure a label that accurately reflects the data from our clinical studies, which included the largest group of patients with cSSSI and the largest group of patients infected with MRSA ever studied. Recent reports from the Centers for Disease Control and Prevention, the subject of an article and editorial in the Journal of the American Medical Association concerning MRSA infections, only serve to highlight the urgent need for more therapeutic options."