Mortality Vs. Clinical Cure: Telavancin Review Expected To Renew Debate On Nosocomial Pneumonia Endpoints
This article was originally published in The Pink Sheet Daily
FDA’s Anti-Infective Drugs Advisory Committee will take up Theravance’s Vibativ NDA on Nov. 29 following two “complete response” letters and the sponsor’s rejected requests for dispute resolution, in which it has argued it should not be held to the standards set forth in a 2010 draft guidance.
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Clinical response data in Theravance’s nosocomial pneumonia studies are difficult to interpret because some patients died shortly after being deemed as cured, the agency says. However, FDA’s statistical reviewer concedes the problem may be a lack of specificity in the 28-day window for assessing mortality.
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.
The Anti-Infective Drugs Advisory Committee votes 13-2 in favor of a limited indication for Theravance’s antibiotic, particularly for use in treating methicillin-resistant infections. The endorsement comes after a nearly four-year regulatory battle over the NDA.