UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events |
On September 11, 2019, the U.S. Food and Drug Administration (FDA) confirmed the previous tentative date, November 14, 2019, as the scheduled date for the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to review the supplemental new drug application (sNDA) related to the REDUCE-IT™ cardiovascular outcomes trial of Vascepa® (icosapent ethyl) capsules.
As expected, later that day, Amarin Corporation, plc received notice from the FDA that the Prescription Drug User Fee Act (PDUFA) goal date in connection with the FDA’s review of the REDUCE-IT sNDA has been extended to the date previously announced as expected, December 28, 2019. The originally assigned PDUFA date was September 28, 2019. This typical three-month extension offsets three of the four months that would have been gained from the FDA’s earlier determination to conduct a priority review of the REDUCE-IT sNDA and accommodates the time period for the EMDAC meeting. Standard 10-month review of the REDUCE-IT sNDA would have resulted in a PDUFA goal date in late January 2020.
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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: September 12, 2019 |
Amarin Corporation plc | |||||
| By: |
/s/ John F. Thero | |||||
| John F. Thero | ||||||
| President and Chief Executive Officer | ||||||