Theravance Biopharma, Inc. recently announced in a press release the presentation of new data on VIBATIV® (telavancin), the company’s FDA-approved antibiotic, at the American Thoracic Society (ATS) 2016 International Conference, May 13-18 in San Francisco.
The data, to be presented in poster form, relates to post hoc analyses of the completed Phase 3 ATTAIN (Assessment of Telavancin for Treatment of Hospital-Acquired Pneumonia) clinical trial studies, which support the drug’s regulatory approval for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).
VIBATIV® is a dual-mechanism bactericidal, once-daily, injectable lipoglycopeptide antibiotic that proved to be effective against difficult-to-treat Gram-positive infections. The drug is approved in the U.S. for the treatment of adult patients with HABP and VABP caused by Staphylococcus aureus, and also 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) S. aureus strains.
MSSA and MRSA strains represent large scale health concerns, as they are a major causes for both HABP and VABP.
Theravance reveals extensive laboratory and animal testing evidence of the drug’s potency and activity against a broad range of Gram-positive bacterial pathogens. VIBATIV (telavancin) is the company’s first commercial product.
A team of researchers at Weill Cornell Medical Center/Medical College and Baystate Medical Center, in collaboration with Theravance Biopharma, conducted further analyses of the previously completed clinical trial in order to evaluate and compare the results from ATTAIN studies in terms of clinical cure and safety for telavancin in comparison to vancomycin.
According to the findings, there are specific HABP/VABP patient populations, including those with MRSA for which VIBATIV may serve as an appropriate treatment. According to the abstract’s conclusions, the drug is a treatment alternative especially for elderly patients and those diagnosed with VABP. However, potential benefits in efficacy and overall survival must be balanced with possible increased risk for damaging effects to the kidneys called nephrotoxicity.
The poster, titled “Clinical Efficacy and Safety of Telavancin in Hospital-Acquired and Ventilator-Associated Pneumonia (HAP/VAP) Patients with Monomicrobial S. aureus Infection”, will be presented May 15.
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