Amarin Corp.'s fish oil drug wins FDA approval to treat high blood fat levels
Vascepa is indicated an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia
Amarin had submitted its New Drug Application(NDA) for the use of Vascepa in this indication in September 2011.
"FDA approval of Vascepa represents theintroduction of an important new treatment option for patients with severehypertriglyceridemia. In Amarin's MARINE clinical trial, Vascepa demonstrated astatistically significant placebo-adjusted reduction in levels of triglycerideswithout elevation in levels of LDL-C, commonly referred to as 'badcholesterol,'" said Joseph Zakrzewski, chairman and CEO of Amarin. "Amarincontinues to anticipate commercial launch of Vascepa early in the first quarterof 2013, and we continue to consider three potential paths for the marketing andsale of the product: an acquisition of Amarin, a strategic collaboration, orself-commercialization, the latter of which could include third-party support.We are now focused on continued commercial preparations for Vascepa whichincludes, but is not limited to, finalizing the introduction of Vascepa tomanaged care plans to gain formulary access, building-up inventory levels andcoordinating other pre-launch marketing activities."
The efficacy and safety of Vascepa were assessedin Amarin's MARINE clinical trial, a randomized, placebo-controlled,double-blind, parallel-group study of adult patients with very high fastingtriglyceride levels, between 500 mg/dL and 2000 mg/dL. At baseline, 25 percentof patients were on concomitant statin therapy, 28 percent suffered fromdiabetes, and 39 percent of patients had TG levels greater than 750 mg/dL.Patients treated for 12 weeks with the 4-gram dose of Vascepa demonstrated astatistically significant placebo-adjusted median TG reduction of 33 percentand did not show an increase in LDL-C levels relative to placebo. Vascepa at 4grams per day also showed statistically significant placebo-adjusted medianreductions from baseline in non-HDL-C (total cholesterol less "goodcholesterol") of 18 percent, total cholesterol of 16 percent, very lowdensity lipoprotein cholesterol of 29 percent, and apolipoprotein B of 9percent.
The most commonly reported adverse reaction inVascepa treated patients was joint pain.
Amarin said it has made "significant progress" inits efforts to expand the patent protection for Vascepa in the United States toat least 2030 with seven patent applications either issued, allowed or inprogressed states of prosecution and more than 25 additional U.S. applicationspending. Amarin is awaiting a decision from FDA as to whether Vascepa will begranted five-year new chemical entity (NCE) or three-year new product marketingexclusivity under the provisions of the Hatch-Waxman amendments to the FederalFood, Drug, and Cosmetic Act.