Friday, April, 19, 2019 04:37:18

The updates were informed by newly published research covering results from REDUCE-IT trial and were crafted and approved by the Professional Practice Committee of ADA

Pharmaceutical company Amarin Corporation plc has recently confirmed that important updates have been issued by the American Diabetes Association (ADA) regarding its 2019 Standards of Medical Care in Diabetes (Standards of Care). Apparently, these include updates related to the results from the cardiovascular outcomes study, REDUCE-IT.

A news release from Amarin suggests that the updates related to REDUCE-IT were informed by newly published research covering results from REDUCE-IT, besides being crafted and approved by the Professional Practice Committee of ADA, which is responsible for deploying the annual Standards of Care.

The update from Standards of Care references icosapent ethyl, a drug studied in REDUCE-IT, that is seemingly marketed by Amarin under the brand name Vascepa capsules. The U.S. Food and Drug Administration (FDA) had approved the use of Vascepa as an addition to diet for reducing adult patients’ triglyceride levels, who are suffering from severe (≥500 mg/dL) hypertriglyceridemia.

Reportedly, Amarin has started transferring data to the FDA for supporting the submissions of a supplemental new drug application, or sNDA, looking towards expanding the FDA label of Vascepa on the basis of results from REDUCE-IT.

Sources familiar with the commented that the FDA has not reviewed and suggested on a sNDA regarding REDUCE-IT. As a general policy of the organization, ADA does not offer any form of certification or endorsements for brand name or commercial products. The drug, icosapent ethyl’s inclusion in the Standards of Care from ADA should not be understood as an approval or endorsement of Vascepa by ADA.

The Living Standards of Care now purportedly includes the recommendation, on the basis of results of REDUCE-IT 2, 3 in both secondary and primary prevention populations, that icosapent ethyl could be considered for patients suffering from diabetes and atherosclerotic cardiovascular disease (ASCVD) or any other risk factors related to cardiac, having elevated triglycerides (135-499) and controlled low-density cholesterol (LDL-C), for reducing cardiovascular risk.