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FDA Panel Breathes New Life Into Telavancin For Nosocomial Pneumonia

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

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Surrogate Endpoints Are Dangerous Path For New Antibiotics – JAMA Editorial

Expedited pathways for acute bacterial infection treatments may increase number of new products at expense of safety and effectiveness, University of Washington doctors warn in JAMA Internal Medicine. Authors criticized trial designs used for Cubist’s Sivextro, Durata’s Dalvance and Theravance’s Vibativ.

Mortality Vs. Clinical Cure: Telavancin Review Expected To Renew Debate On Nosocomial Pneumonia Endpoints

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requests for dispute resolution, in which it has argued it should not be held to the standards set forth in a 2010 draft guidance.

Theravance’s Vibativ To Get FDA Panel Review For Hospital-Acquired Pneumonia

Theravance has received two complete response letters but says it does not plan to do additional clinical studies for the new indication; Vibativ production has been halted in the U.S. and its marketing authorization withdrawn in Europe.


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