Theravance works to resolve FDA issues on new skin-infection treatment

South San Francisco, Calif. - Theravance Inc., based here, and partner Astellas Pharma US Inc., an affiliate of Japan’s Astellas Pharma Inc., have received a Food and Drug Administration approvable letter asking for additional clinical information on the drug telavancin to treat skin infections caused by gram-positive bacteria, news source rttnews.com reports.

Telavancin is a bactericidal, once-daily injectable antibiotic developed by Theravance. The company says its telavancin application is approvable pending the resolution of manufacturing-practices compliance issues not specifically related to the drug at a third-party manufacturer, and on submission of revised labeling or re-analyses of clinical data or additional clinical data.

Both companies say they believe no additional clinical studies will be needed to respond to the FDA’s approvable letter. Two years ago, Theravance partnered with Astellas Pharma to develop and market televancin globally.

In the Theravance statement, CEO Rick Winningham says, “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 infected with methicillin-resistant Staphylococcus aureus (MRSA) ever studied.”