A key scientific panel of the US medicines regulator has voted unanimously in favor of granting a label expansion for Amarin’s (Nasdaq: AMRN) Vascepa (icosapent ethyl).
A favorable verdict was widely anticipated, after the release of Food and Drug Administration briefing notes in advance of Thursday’s meeting. While the agency is not bound to follow the advice of the panel, it generally does.
While Vascepa has been approved to reduce triglycerides since 2012, the broader label would allow marketing to reduce the risk of cardiovascular events in high-risk patients on standard-of-care statin therapy.
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
7 day trial access
Become a subscriber
Or £77 per month
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
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze