Fish oil drug could be worth billions for Amarin

15 November 2019

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.

Try before you buy

Free

7 day trial access

Take a Free Trial

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

Subscribe Now

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