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Amarin Corp. plc, the Irish drug company with research headquarters in Groton, announced Tuesday that U.S. regulators have agreed to review its fish-oil medication Vascepa for an expanded group of patients not covered by similar prescription remedies.
The Food and Drug Administration accepted Amarin's supplemental new drug application, the company said, setting a Dec. 20 target for possible approval of the new indication, for a group of patients with blood fat called triglycerides in the 200 to 499 micrograms-per-deciliter range.
The supplementary indication would add significantly to Amarin's market for the heart drug Vascepa, which studies have shown lower artery-clogging fat content in the blood. The market for Americans with very high triglyceride levels is estimated at about 4 million, while the population affected by the supplemental indication of slightly lower blood fat has been put at 75 million.
"Vascepa is unique in that it significantly lowered both triglycerides and LDL (bad) cholesterol on top of optimized statin therapy (such as Pfizer Inc.'s drug Lipitor)," said Amarin Chairman and Chief Executive Joseph S. Zakrzewski in a statement.
News of the FDA's agreement to review Vascepa for a new indication failed to halt the continued erosion of Amarin's stock price on the Nasdaq exchange. Amarin's stock closed the day at $6.65 a share, down nearly 3 percent and just above its one-year low.
Amarin's stock started to sink after the company decided late last year to sell Vascepa on its own rather than take on a marketing partner. The price is off more than 50 percent from its high last year.
The FDA last June approved the use of Vascepa, previously known as AMR101, for patients with very high triglyceride levels. The regulatory agency so far has not designated the drug as a new chemical entity because of its similarity to the fish-oil medication Lovaza marketed by GlaxoSmithKline.