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Health and Healthcare

Theravance Gets FDA Nod on Vibativ

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By Chris Lange Updated Published
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Theravance Gets FDA Nod on Vibativ

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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.
[nativounit]
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.

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About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.

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