Pink Sheet is part of the Business Intelligence Division 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

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

This article was originally published in The Pink Sheet Daily

Executive Summary

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).

Advertisement

Related Content

The SHARP “Approval”: Merck Gets Vytorin Labeling Change, But Not The CV Outcomes Claim It Sought
Merck’s Bid For Vytorin CV Benefit Claim Muddied By Earlier Statin Failures In Dialysis Patients
Vytorin: Yesterday’s News?
Merck's Vytorin/Zetia Headed For CV Outcomes Claim, But Will Dialysis Patients Be Off-Limits?
FDA Cmte. To Weigh Breadth Of Vytorin/Zetia CV Risk Reduction Claim In Renally Impaired Patients
What Statins Can’t Achieve: Failed AURORA Study Reinforces ESRD Doubts

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS073294

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