FDA panel favors restricted Vibativ label extension

FDA's Anti-Infective Drugs Advisory Committee voted 13-2 to recommend expanding the label for Vibativ telavancin from Theravance Inc. (NASDAQ:THRX) to include treating nosocomial pneumonia when other alternatives are not suitable. The panel also voted 9-6 against expanding Vibativ's label to treat nosocomial pneumonia without the restriction of unsuitable alternatives.

Committee members were concerned that Vibativ only demonstrated non-inferiority to vancomycin on the endpoint of all-cause mortality at 28 days in one of two Phase III trials. Vibativ met the pre-defined primary endpoint of clinical cure at 7-14 days in both studies but FDA has issued draft guidance recommending use of the mortality endpoint in nosocomial pneumonia trials. ...