FDA approves Vascepa for severe hypertriglyceridemia
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."