FDA panel gives unanimous backing for Merck & Co's Vytorin for some kidney disease patients
US drug giant Merck & Co (NYSE: MRK) said yesterday that the Endocrinologic and Metabolic Drugs Advisory Committee of the US Food and Drug Administration voted unanimously (16 to 0) to recommend approval of the firm’s blockbuster cholesterol lowerer Vytorin (ezetimibe/simvastatin) for use in patients with pre-dialysis chronic kidney disease. Merck’s shares edged nearly 1% higher to $34.19 on the news in November 2 New York trading.
The Committee's vote was mixed (with the majority not in favor) regarding whether there is sufficient evidence to support approval specifically for patients with end-stage renal disease who are receiving dialysis, the company noted. Merck is seeking indications for Vytorin and for Zetia (ezetimibe) in combination with simvastatin to reduce the risk of major cardiovascular events in patients with chronic kidney disease based on the results of the Study of Heart and Renal Protection (SHARP) trial. Neither product is currently indicated for this use.
Final FDA decision expected 1st-qtr 2012
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
- Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
- Daily roundup of key events in pharma and biotech.
- Monthly in-depth briefings on Boardroom appointments and M&A news.
- Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
More on this story...
Today's issue
Company Spotlight
More Features in Pharmaceutical
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze