Theravance Gets To Market With Vibativ, But HAP Indication Could Be Pushed To 2010
This article was originally published in The Pink Sheet Daily
Theravance expects an FDA advisory committee review for Vibativ in hospital acquired pneumonia; product partnered with Astellas is approved for complicated skin infections.
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The biotech is bringing is long-plagued antibiotic back to U.S. patients, but is still searching for another company to help with commercialization efforts. Meanwhile, plans for its split and the launch of its partnered COPD drug are on track.
Company has secured a new third-party manufacturer for the antibiotic and says it will relaunch the drug in the third quarter. FDA approval for telavancin’s use in hospital-acquired pneumonia comes four-and-a-half years after the original NDA submission for the supplemental claim.
FDA’s Anti-Infective Drugs Advisory Committee endorsed Vibativ for limited use in nosocomial pneumonia. The committee was convened at the recommendation of Office of New Drugs Director John Jenkins, who denied the company’s appeal of a second “complete response” letter but urged the NDA be re-evaluated.