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

Merck's Vytorin/Zetia Headed For CV Outcomes Claim, But Will Dialysis Patients Be Off-Limits?

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA's Endocrinologic and Metabolic Drugs Advisory Committee unanimously endorses cardiovascular risk reduction claim for pre-dialysis chronic kidney disease patients, but votes 10-6 against extending the indication to the dialysis setting due to efficacy concerns.

You may also be interested in...



IMPROVE-IT Study: Negative Panel Review Leaves FDA With Tough Choice

Approval of cardiovascular risk reduction claims for Merck's Zetia and Vytorin would fly in the face of advisory committee's recommendations, but rejection would mean the first outcomes study to show CV benefit for a non-statin, LDL-C-lowering agent did not provide substantial evidence.

The SHARP “Approval”: Merck Gets Vytorin Labeling Change, But Not The CV Outcomes Claim It Sought

FDA opted against a new indication for the ezetimibe/simvastatin combination because the SHARP trial in chronic kidney disease patients did not assess the independent contributions of each drug on the observed effect. There was no indication at a November advisory committee review that issues related to the “combination rule” would pose a barrier to a new claim.

Vytorin/Zetia Affirmation Continues To Elude Merck With Denied CKD Indication

FDA shot down Merck’s bid to add an indication for cardiovascular risk reduction in renally impaired patients to Vytorin (ezetimibe/simvastatin) labeling, arguing the contribution of the two components to positive results wasn’t measured in the pivotal SHARP trial. Trial data can be added to the Vytorin label but not to labeling for Zetia (ezetimibe).

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS073002

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