The FDA outlined new information it would need from Theravance and Astellas before it can fully approve telavancin, a new antibiotic that can be used against 'superbug' staph infections. But researchers say that the companies would not need to mount a new clinical trial in order to satisfy the FDA's demands. The FDA's letter includes a request for more clinical data or reanalyzed clinical data, revised labeling and a resolution of good manufacturing practices.
"We are committed to submitting a timely and complete response to this approvable letter," said Rick E. Winningham, the chief executive of Theravance. "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 (superbug staph) ever studied." Theravance was a 2003 Fierce 15 company.
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