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:          
CWWeekly

May 18

Research for All Act reaches Congress for second time seeking gender equality in basic research, clinical trials

MediciGlobal finds fewer trial dropouts among participants who actively pursue enrollment versus those recruited

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

May

Job satisfaction mixed as workload increases
Salaries not keeping pace with rise in work, responsibilities

Gamification moving from early science to patient use
Pharma looking to use games for early diagnosis, recruitment, adherence

Already a subscriber?
Log in to your digital subscription.

Purchase the May issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

Already a subscriber?
Log in to your digital subscription.

Purchase the April issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs