Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Avandia Committee Gives Split Vote To Drug, But FDA Clear Winner

Executive Summary

A re-adjudication of cardiovascular events in the RECORD trial reassured members of a June 5-6 advisory committee that the study findings are reliable, but did not erase uncertainties about CV risk associated with rosiglitazone.

You may also be interested in...



FDA Polled Review Staff On Avandia REMS Changes

Decision to replace the rosiglitazone REMS’ distribution restrictions with prescriber training reflected a consensus opinion shared by leadership in three CDER offices, despite a poll of reviewers who participated in a June advisory committee meeting and favored eliminating the risk management program.

FDA Replaces Avandia REMS Distribution Restrictions With Prescriber Training

Comforted by the re-adjudicated RECORD results, agency directs rosiglitazone sponsors to provide training “based on the current state of knowledge” about the diabetes drug’s cardiovascular risk but eliminates the requirement that links drug access to provider, pharmacy and patient enrollment in the REMS.

Will CV Verdicts For Onglyza, Nesina Cause FDA To Change Its Tune On Antidiabetic Safety?

Large outcomes studies showed neither cardiovascular harm nor benefit with BMS/AstraZeneca’s saxagliptin or Takeda’s alogliptin, prompting some commenters to question whether FDA’s blanket approach to CV safety for all antidiabetic agents needs adjustment.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS055405

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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