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Theravance Receives FDA Approval For VIBATIV For HABP/VABP - Quick Facts

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6/21/2013 5:41 PM ET

Theravance, Inc. (THRX: Quote) announced that the U.S. Food and Drug Administration or FDA has approved VIBATIV or telavancin for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia or HABP/VABP caused by susceptible isolates of Staphylococcus aureus when alternative treatments are not suitable.

The company said that VIBATIV is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with a dual mechanism of action whereby telavancin both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function.

Theravance stated that in 2009, VIBATIV was approved in the U.S. for the treatment of complicated skin and skin structure infections caused by susceptible isolates of Gram-positive bacteria, including Staphylococcus aureus, both methicillin-susceptible and methicillin-resistant strains.

The company noted that ATTAIN I and ATTAIN II were two large, multi-center, multinational, double-blind, randomized Phase 3 clinical studies, in which 1,503 adult patients were enrolled and treated, 464 of whom were infected with MRSA.

Patients with HABP suspected or proven to be caused by Gram-positive bacteria were randomized to receive either telavancin 10 mg/kg IV once daily or vancomycin 1 gram IV every 12 hours. The objective of each study was non-inferiority of VIBATIV versus vancomycin in clinical cure rate at the test-of-cure visit. Determination of clinical cure was based upon physician-judged resolution of clinical signs and symptoms of HABP.

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by RTT Staff Writer

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