Health and Healthcare

Theravance Gets FDA Nod on Vibativ

Chris Lange

Published: May 9, 2016 10:25 am

Last Updated: January 13, 2020 9:41 am

Theravance Biopharma Inc. (NASDAQ: TBPH) saw its share take a slight tick up on Monday morning following a U.S. Food and Drug Administration (FDA) approval. The company announced that the FDA 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 bacteremia (SAB) in both of the antibiotic’s currently approved indications in the United States.

Vibativ is approved in the United States for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus when alternative treatments are not suitable. Additionally, Vibativ is approved in the United States for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria, including Staphylococcus aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains.

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).

Separate from this, Theravance Biopharma is currently conducting a Phase 3 registrational study of telavancin in patients with complicated SAB. 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 United States 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.

Shares of Theravance were trading up 3% at $18.50 Monday morning, with a consensus analyst price target of $20.00 and a 52-week trading range of $10.56 to $24.76.