Amarin Corp. plc, an Irish company with research headquarters in Groton, said Tuesday that it has submitted to the U.S. Food and Drug Administration an application to expand the market for its new heart medication Vascepa.
The supplemental application seeks approval to target millions of new potential Vascepa patients who have elevated levels of a certain type of fat in the blood known as triglycerides. The FDA already has approved Vascepa for patients with very high triglyceride levels.
Amarin said it expects the FDA to decide on whether to review the supplemental application within a month and a half.
- Lee Howard