Amarin Corporation plc (NASDAQ:AMRN) Stock Trading Halted Today for Scheduled FDA Advisory Committee Review of sNDA Seeking New Indication for Vascepa® (Icosapent Ethyl) to Reduce the Risk of Major Adverse Cardiovascular Events Based on Landmark REDUCE-I
DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 14, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company focused on improving cardiovascular health, today announced that NASDAQ has halted trading of the company's shares. The U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC), as previously scheduled and announced, is meeting today to openly discuss the company's supplemental New Drug Application (sNDA) seeking a new indication for Vascepa® (icosapent ethyl) to reduce the risk of major adverse cardiovascular events based on the landmark REDUCE-IT® cardiovascular outcomes study.
The Advisory Committee meeting is scheduled for 8:00 a.m. ET. The briefing materials can be found on the FDA website at https://www.fda.gov/advisory-committees/november-14-2019-meeting-endocrinologic-and-metabolic-drugs-advisory-committee-meeting-announcement. The Prescription Drug User Fee Act (PDUFA) goal date for the FDA’s review of Vascepa’s supplemental New Drug Application is December 28, 2019.
The EMDAC reviews and evaluates data concerning the effectiveness and safety of marketed and investigational human drug products under review at the Division of Metabolism and Endocrinology Products at FDA and makes appropriate recommendations to the division. The FDA is not bound by the recommendations of an advisory committee.
Amarin Corporation plc is a rapidly growing, innovative pharmaceutical company focused on developing therapeutics to improve cardiovascular health. Amarin’s product development program leverages its extensive experience in polyunsaturated fatty acids and lipid science. Vascepa (icosapent ethyl) is Amarin's first FDA-approved drug and is available by prescription in the United States, Lebanon and the United Arab Emirates. Amarin’s commercial partners are pursuing additional regulatory approvals for Vascepa in Canada, China and the Middle East. For more information about Amarin, visit www.amarincorp.com.
Availability of Other Information About Amarin
Investors and others should note that Amarin communicates with its investors and the public using the company website http://www.amarincorp.com/), the investor relations website (http://investor.amarincorp.com/), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
Amarin Contact Information
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
Lee M. Stern
In U.S.: +1 (646) 378-2992
Amarin Corporation plc
In U.S.: +1 (908) 325-0735