UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): November 14, 2019
Amarin Corporation plc
(Exact name of registrant as specified in its charter)
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England and Wales | | 0-21392 | | Not applicable |
(State or other jurisdiction of incorporation) | | (Commission File Number) | | (I.R.S. Employer Identification No.) |
| | |
77 Sir John Rogerson’s Quay, Block C, Grand Canal Docklands, Dublin 2, Ireland | | Not applicable |
(Address of principal executive offices) | | (Zip Code) |
Registrant’s telephone number, including area code: +353 1 6699 020
Not Applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| | ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| | ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| | ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| | ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class | | Trading Symbol | | Name of each exchange on which registered |
American Depositary Shares (ADS(s)), each ADS representing the right to receive one (1) Ordinary Share of Amarin Corporation plc | | AMRN | | NASDAQ Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
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.
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Date: November 15, 2019 | | | | Amarin Corporation plc |
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| | | | By: | | /s/ John F. Thero |
| | | | | | John F. Thero |
| | | | | | President and Chief Executive Officer |
