FDA expands Vibativ label to pneumonia

FDA approved a label expansion for antibiotic Vibativ telavancin from Theravance Inc. (NASDAQ:THRX) to include the treatment of hospital-acquired (nosocomial) and ventilator-associated pneumonia caused by Staphylococcus aureus when alternative treatments are not suitable. The approval -- which is in line with a November recommendation from FDA's Anti-Infective Drugs Advisory Committee -- is the first for an antibiotic to treat nosocomial pneumonia since 2000 (see BioCentury, Dec. 3, 2012).

The injectable lipoglycopeptide antibiotic is already approved in the U.S. to treat complicated skin and skin structure infections (cSSSIs) caused by susceptible Gram-positive bacteria. Vibativ also is approved in the EU to treat nosocomial pneumonia, including ventilator-associated pneumonia known or suspected to be caused by methicillin-resistant S. aureus (MRSA). The antibiotic is currently in shortage in the U.S., but Theravance said Vibativ will be available to wholesalers again in 3Q13. ...