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Amarin Hooks FDA Approval for Prescription-Grade Fish Oil

By Peter Winter
BioWorld Insight Editor

As expected, the FDA gave the green light last Thursday to Amarin Corp. plc'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 500 mg/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, a gain of 73 cents on the day.

The company's new drug application (NDA) for Vascepa was submitted to the FDA on Sept. 26, 2011, and was supported by data from the company's MARINE clinical trial. Data showed that adult patients with very high fasting triglyceride levels (between 500 mg/dL and 2,000 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 g 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 research note by Leerink Swann analyst Joseph P. Schwartz that was based on a survey of more than 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), which according to GSK's 2011 annual report, recorded sales of £569 million (US$892 million). Vascepa also is 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 or three-year new product marketing exclusivity under the provisions of the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act. Typically, the FDA's determination on the exclusivity of approved products is made public through the posting on the agency's website in the Orange Book. That normally occurs mid-month following the month of an NDA approval, the company added.