FDA approves Vascepa for severe hypertriglyceridemia

Friday, July 27, 2012 10:53 AM

The FDA has approved Vascepa (icosapent ethyl) capsules as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (TG ≥ 500mg/dL), according to Amarin, a Bedminster, N.J.-based biopharmaceutical company focused on cardiovascular health.

"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,’” said Joseph Zakrzewski, chairman and CEO of Amarin.

In the MARINE study, adult patients with very high fasting triglyceride levels were treated for 12 weeks with the 4g dose of Vascepa. Results demonstrated a statistically significant placebo-adjusted median triglyceride reduction of 33% (p < 0.001), and did not show an increase in LDL-C levels relative to placebo. Vascepa also showed statistically significant placebo-adjusted median reductions from baseline in non-HDL-C of 18%, total cholesterol of 16%, VLDL-C of 29% and apolipoprotein B of 9%.

“Amarin continues to anticipate commercial launch of Vascepa early in the first quarter of 2013,” said Zakrzewski. “We continue to consider three potential paths for the marketing and sale of the product: an acquisition of Amarin, a strategic collaboration or self-commercialization, the latter of which could include third-party support. We are now focused on continued commercial preparations for Vascepa which includes, but is not limited to, finalizing the introduction of Vascepa to managed care plans to gain formulary access, building-up inventory levels and coordinating other pre-launch marketing activities."

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

September 29

WCG sees ePharmaSolutions’ clinical trial portal as the next step in the data evolution, company mission

Cutting-edge advertising can ‘break through the clutter’ for successful patient recruitment

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

September

Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

From the trenches: Sites' eye view of state of the industry
CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

Already a subscriber?
Log in to your digital subscription.

Purchase the September issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

Already a subscriber?
Log in to your digital subscription.

Purchase the August issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs