Theravance Biopharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental New Drug Application (sNDA) for VIBATIV® (telavancin) to expand the product's label to include data describing the treatment of patients with concurrent Staphylococcus aureus (S. aureus) bacteremia in both of the antibiotic's currently approved indications in the United States.
VIBATIV is approved in the U.S. for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of S. aureus when alternative treatments are not suitable. In addition, VIBATIV is approved in the U.S. for the treatment of adult patients with complicated skin & skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria, including S. aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains.
"When patients with cSSSI or HABP/VABP present with concurrent bacteremia, their treatment becomes more difficult for healthcare practitioners. With this action by the FDA, we believe an important advance has been made in addressing the unique challenges in this area. The additional data that are now reflected in the VIBATIV label address the use of VIBATIV in cSSSI and HABP/VABP with concurrent bacteremia and we are now implementing a strategy to communicate this information to targeted healthcare practitioners," said Frank Pasqualone, Senior Vice President and Global Head, Acute Care Business at Theravance Biopharma. "With the broader medical need for effective bacteremia treatments in mind, we are also conducting a Phase 3 registrational study of telavancin in primary complicated S. aureus bacteremia, which we expect to complete in late 2017 or early 2018. Should we prove successful with this trial and secure approval in this infection type, VIBATIV would possess the broadest set of indications of any branded anti-MRSA agent."
The sNDA filing was based on the combined data from Theravance Biopharma's previously conducted pivotal trials of VIBATIV in its two approved indications -- cSSSI (ATLAS I and II) and HABP/VABP (ATTAIN I and II). The trials were large, multi-center, multinational, double-blind, randomized Phase 3 clinical studies enrolling and treating 3,370 adult patients, including a portion of patients with concurrent bacteremia.
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