Thursday, December 1, 2016

Theravance Biopharma Announces FDA Approval of Expanded Label for Vibativ (telavancin)

In continuation of my update on telavancin

Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the "Company") today 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.
Bacteremia is the presence of bacteria in the bloodstream and can occur spontaneously or in the presence of other infections. Bacteremia continues to represent a significant unmet medical need. Concurrent bacteremia, which in its most serious form is fatal, occurs when bacteria spreads from its initial infection site and enters the bloodstream. As a secondary infection, it introduces significant challenges to the treatment of the primary infection, as well as the concurrent bacteremia itself.
"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. Importantly, these studies involved two of the largest cohorts of patients ever studied in these diseases and included one of the largest cohorts of patients with MRSA infections studied to date.

Expanded Vibativ Label Data

The data added to the Vibativ label describe patients with concurrent S. aureus bacteremia in the Phase 3 ATLAS and ATTAIN trials. These include:
  • In the all-treated cSSSI patient population with baseline S. aureus bacteremia in the ATLAS I and II trials, clinical cure rates at test-of-cure were 57.1% for Vibativ-treated patients vs. 54.6% for vancomycin-treated patients.
  • In the HABP/VABP patient population with at least one Gram-positive respiratory pathogen at baseline who had concurrent S. aureus bacteremia in the ATTAIN I and II trials, the 28-day all-cause mortality rate was 40.0% for Vibativ-treated patients vs. 39.5% for vancomycin-treated patients.
Separately, Theravance Biopharma is currently conducting a Phase 3 registrational study of telavancin in patients with complicated S. aureus bacteremia. The trial is a multi-center, randomized, open-label study that is enrolling approximately 250 adult patients with confirmed MSSA or MRSA bacteremia at about 70 clinical sites in the U.S. and around the world. Researchers are evaluating telavancin in treating these patients as compared to standard therapies such as vancomycin, daptomycin and anti-staphylococcal penicillins. The trial is expected to be completed in late 2017 or early 2018.

No comments: