Amarin Corporation plc (NASDAQ:AMRN) rose Thursday. Amarin confirmed that the American Diabetes Association issued important updates to Standards of Medical Care in Diabetes for 2019.
The company, based in Bedminster, New Jersey, and also with headquarters in Dublin, confirmed that the ADA issued important updates to the Standards of Medical Care in Diabetes for 2019 (Standards of Care), including updates related to the results of the REDUCE-IT™ cardiovascular outcomes study.
The REDUCE-IT related updates were informed by newly published research covering REDUCE-IT results and crafted and approved by the ADA’s Professional Practice Committee, which is responsible for producing the annual Standards of Care. The Living Standards of Care are available online at Diabetes Care
A news release out Thursday stated that the Standards of Care update references the drug, icosapent ethyl, studied in REDUCE-IT, which Amarin markets under the brand name, Vascepa® (icosapent ethyl) capsules.
Vascepa has been approved for use by the United States Food and Drug Administration (FDA) as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. Amarin has commenced transmission of data to the FDA to support the submission of a supplemental new drug application seeking an expansion of the Vascepa FDA label based on the landmark REDUCE-IT results.
"Accordingly," it continues, "FDA has not reviewed and opined on a sNDA related to REDUCE-IT. ADA does not provide endorsements or any form of certification for brand name commercial products as a general policy of the organization."
Shares acquired 63 cents, or 3.5%, to $18.71
