Vascepa® (Icosapent Ethyl) by Amarin Granted Approval in the Kingdom of Saudi Arabia (KSA) to Decrease Cardiovascular Risk
Thursday, June 22, 2023
Amarin Corporation plc (NASDAQ: AMRN) and its commercialization partner Biologix FZco have jointly announced the approval of a new indication and label expansion for VASCEPA® (icosapent ethyl) capsules by the Saudi Food and Drug Authority (SFDA) in the Kingdom of Saudi Arabia (KSA). This approval by SFDA makes VASCEPA the first and only drug to be approved as an adjunct to statin therapy for adult patients in KSA with elevated triglyceride levels (≥150 mg/dL) who are at a high risk of cardiovascular events due to established cardiovascular disease or diabetes mellitus, along with at least one other risk factor for cardiovascular disease.
Cardiovascular disease (CVD) poses a significant health concern in KSA, with over 30 percent of adults being at risk of experiencing a CVD event. The approval of VASCEPA by SFDA represents a crucial development in addressing this urgent need. Dr. Steven Ketchum, President of Research & Development and Chief Scientific Officer at Amarin, expressed enthusiasm regarding the approval and the potential benefits that VASCEPA can offer to patients in KSA. This approval also aligns with Amarin's strategic objective of expanding the global availability of VASCEPA/VAZKEPA for cardiovascular risk reduction, leveraging the positive outcomes observed in the REDUCE-IT outcomes trial. By pursuing this strategy, Amarin aims to extend the cardiovascular risk reduction benefits of VASCEPA/VAZKEPA to millions of patients worldwide.
The inclusion of icosapent ethyl (IPE) in the guidelines of the Saudi National Diabetes Center (SNDC) and The National Heart Center (NHC) for diabetes and dyslipidemia emphasizes its potential in reducing cardiovascular risk when used as an adjunct to statin therapy in patients with elevated and high triglyceride levels. The incorporation of IPE in the Saudi Diabetes Clinical Practice Guidelines (SDCPG)-2021 was based on the findings of the REDUCE-IT trial and related publications, even before its registration in KSA.
Under their existing agreement, Amarin and Biologix have allocated responsibilities for registering VASCEPA in the licensed territory and managing marketing, sales, and distribution services. While Biologix assumes these responsibilities, Amarin will provide regulatory support, supply the product, and maintain intellectual property rights in the region.
