The US regulatory body has sent Theravance and its partner Astellas Pharma US Inc, affiliate of Tokyo-based Astellas Pharma, an approvable letter indicating that the telavancin application is approvable, subject to: resolution of current good manufacturing practices compliance issues not specifically related to telavancin at a third-party manufacturer; and submission of revised labeling or re-analyses of clinical data or additional clinical data. Theravance and Astellas believe that no additional clinical studies will need to be initiated to respond to the approvable letter.
Rick Winningham, CEO of Theravance, said: “We are committed to submitting a timely and complete response to this approvable letter. 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 complicated skin and skin structure infections and the largest group of patients infected with methicillin-resistant Staphylococcus aureus (MRSA) ever studied.”