Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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

This article was originally published in The Pink Sheet Daily

Executive Summary

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requests for dispute resolution, in which it has argued it should not be held to the standards set forth in a 2010 draft guidance.

You may also be interested in...



Telavancin Review Challenges Adequacy Of FDA’s Favored Mortality Endpoint

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.

Theravance’s Persistence On Telavancin Rewarded With Positive Cmte. Vote

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.

FDA Panel Breathes New Life Into Telavancin For Nosocomial Pneumonia

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.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS073551

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel