FDA approves expanded label for Theravance's Vibativ

Ireland-incorporated Theravance Biopharma (Nasdaq: TBPH) says that the US Food and Drug Administration has approved its 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 USA.

Vibativ is approved in the USA 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 USA for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria, including S. aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains.

The sNDA filing was based on the combined data from Theravance'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, multicenter, multinational, double-blind, randomized Phase III 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.