UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events |
On November 14, 2019, Amarin Corporation plc (the “Company”) announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) voted unanimously (16-0) to recommend approval of an indication and label expansion for Vascepa® (icosapent ethyl) capsules to reduce the risk of cardiovascular events in high-risk patients based on results from the REDUCE-IT® cardiovascular outcomes trial.
The FDA is not bound by the recommendations of an advisory committee. The Company plans to work with the agency as it completes its review of the Company’s supplemental new drug application (sNDA) seeking an appropriate label expansion for Vascepa to reflect the REDUCE-IT results. The FDA is scheduled to make its decision on or before the target PDUFA date of December 28, 2019.
Vascepa is currently approved by the FDA for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (TG ≥500 mg/dL) hypertriglyceridemia.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: November 15, 2019 |
Amarin Corporation plc | |||||
| By: |
/s/ John F. Thero | |||||
| John F. Thero | ||||||
| President and Chief Executive Officer | ||||||