12:00 AM
Dec 03, 2012
 |  BioCentury  |  Regulation

Choice liberates

FDA handling of Theravance's Vibativ may signal new flexibility on antibiotics

The judicious way in which FDA asked its Anti-Infective Drugs Advisory Committee whether to approve Theravance Inc.'s Vibativ telavancin to treat hospital-acquired pneumonia last week may reflect what the agency says is its renewed willingness to work with industry to overcome hurdles slowing development of antibacterial products.

In the U.S., controversy has surrounded the infectious disease regulatory landscape for the better part of a decade as FDA, responding to outside criticism, began requiring more rigorous antibiotic trial designs.

The result, as acknowledged recently on BioCentury This Week television by Edward Cox, director of the Office of Antimicrobial Products at the Center for Drug Evaluation and Research (CDER), was to inadvertently raise the bar for approval to an unreasonable height in some settings (see BioCentury This Week, Nov. 18 & BioCentury, Nov. 19).

Theravance, which began Phase III testing of Vibativ for hospital-acquired (nosocomial) pneumonia (HAP) in 2005, is an example of a company that got left in the lurch.


Between early 2005 and mid-2007, Theravance conducted two double-blind Phase III trials (0015 and 0019) designed to show Vibativ, an injectable lipoglycopeptide antibiotic, is non-inferior to vancomycin in patients with HAP, including those with ventilator-associated pneumonia (VAP).

The studies used clinical response 7-14 days after the last dose as the primary endpoint based on FDA's guidance at the time, which had been in place since 1998.

In both studies, Vibativ met the clinical response endpoint. Based on the results, Theravance submitted an NDA in 2009 requesting approval to treat HAP.

That same year, Vibativ was approved in the U.S. to treat complicated skin and skin structure infections (cSSSIs) caused by susceptible Gram-positive bacteria.

In the meantime, however, the regulatory landscape in the HAP setting had changed (see BioCentury, Nov. 14, 2011).

In 2010, FDA issued new draft guidance recommending that HAP and VAP trials...

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