Amarin Hooks FDA Approval for Prescription-Grade Fish-Oil
BioWorld Insight Editor
As expected the U.S. Food and Drug Administration (FDA) gave the “green-light” on Thursday to Amarin’s 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.
The decision came after the markets had closed and trading of Amarin’s shares had been suspended just over an hour before the close. At that time the shares (NASDAQ: AMRN) were priced at $15.31, 73 cents on the day.
The company’s NDA for Vascepa was submitted to the FDA on September 26, 2011, and was supported by data from the company’s MARINE clinical trial. Data showed that adult patients with very high fasting triglyceridelevels (between 500 mg/dL and 2000 mg/dL) treated for 12 weeks with 4 g per day of Vascepa demonstrated a statistically significant placebo-adjusted median triglyceride reduction of 33 percent (p<0.001), and did not show an increase in LDL-C levels relative to placebo. Vascepa 4 grams per day also showed statistically significant placebo-adjusted median reductions from baseline in non-HDL-C (total cholesterol less “good cholesterol”) of 18 percent. (See BioWorld Today, Nov. 17, 2011.)
According to a June 2012 research note by Learink Swann analyst Joseph P. Schwartz that was based on a survey of over 100 physicians, Vascepa is expected to “significantly expand the prescription omega-3 market.”
The product will compete with GlaxoSmithKline plc’s blockbuster Lovaza (omega-3-acid ethyl ester), and according to GSK’s 2011 annual report, recorded sales of £569 million (US$892 million). Vascepa is also predicted by analysts to reach blockbuster status within three years of market launch.
The company announced that it is awaiting a decision from the FDA as to whether Vascepa will be granted five-year new chemical entity (NCE) or three-year new product marketing exclusivity under the provisions of the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act. Typically, FDA’s determination on the exclusivity of approved products is made public through the posting on FDA’s website in the Orange Book. This normally occurs mid-month following the month of an NDA approval, the company added.
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