US FDA clears Amarin's Vascepa, a competitor for Lovaza

30 July 2012

The US Food and Drug Administration has approved biotech firm Amarin’s (Nasdaq: AMRN) Vascepa (icosapent ethyl) capsules (formerly known as AMR101) as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (TG greater than or equal to 500mg/dL) hypertriglyceridemia (very high triglycerides).

Amarin submitted the New Drug Application for the use of Vascepa in this indication in September 2011. The drug will compete with GlaxoSmithKline’s (LSE: GSK) Lovaza (omega-3-acid ethyl esters), which generated second-quarter sales of £157 million ($245 million) for the US pharma giant.

"FDA approval of Vascepa represents the introduction of an important new treatment option for patients with severe hypertriglyceridemia. In Amarin's MARINE clinical trial, Vascepa demonstrated a statistically-significant, placebo-adjusted reduction in levels of triglycerides without elevation in levels of LDL-C, commonly referred to as 'bad cholesterol,'" stated Joseph Zakrzewski, chairman and chief executive of Amarin.

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