Amarin Announces Vascepa (Icosapent Ethyl) Approved to Reduce Cardiovascular Risk in the Kingdom of Saudi Arabia (KSA)

-- VASCEPA Approved in KSA To Reduce the Risk of Cardiovascular (CV) Events as an Adjunct to Statin Therapy in Adult Patients with Elevated Triglyceride (TG) Levels (≥150 mg/dL) and Other High-Risk Characteristics as Studied in REDUCE-IT--

-- VASCEPA Becomes First and Only Approved Medication in KSA for Reducing CV Risk Beyond Cholesterol Lowering Therapy in High-Risk Statin Treated Patients with Elevated and High Triglyceride Levels --

DUBLIN, Ireland and BRIDGEWATER, N.J., June 21, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) and its commercialization partner Biologix FZco, a company based in the United Arab Emirates and a pioneer in the distribution of pharmaceutical and biological products in the Middle East and North Africa, today announced that the Kingdom of Saudi Arabia’s (KSA) Saudi Food and Drug Authority (SFDA) has approved a new indication and label expansion for VASCEPA (icosapent ethyl) capsules. VASCEPA is now the first and only drug approved by SFDA as an adjunct to statin therapy in adult patients with elevated triglycerides (TG) levels (≥150 mg/dL) who are at high-risk of cardiovascular (CV) events due to established cardiovascular disease or diabetes mellitus and at least one other risk factor for cardiovascular disease.

There is an urgent need to address cardiovascular disease (CVD) in KSA.ⁱ Over 30 percent of adults (18 years) in KSA are at risk of a CVD event.ⁱ

“We are excited that patients in KSA will now have the opportunity to benefit from the proven cardiovascular risk reduction with VASCEPA following the approval by the SFDA,” said Steven Ketchum, PhD., President, Research & Development and Chief Scientific Officer, Amarin. “Today’s approval also marks an important step in our strategy to expand the global footprint where VASCEPA/VAZKEPA is indicated for cardiovascular risk reduction, built from the results seen in the REDUCE-IT outcomes trial. By executing against this strategy, we can bring the cardiovascular risk reduction benefit of VASCEPA/VAKEPA to millions more patients around the world.”

Both the Saudi National Diabetes Center (SNDC) and The National Heart Center (NHC) in their published guidelines for diabetes and dyslipidemia, under the Saudi Health Council (SHC), mention icosapent ethyl (IPE) for CV risk reduction as an adjunct to statin therapy in patients with elevated and high TG levels.^ii,iiiThe inclusion of IPE in the Saudi Diabetes Clinical Practice Guidelines (SDCPG)-2021 was done based on the results of the REDUCE-IT trial and publications, and prior to product registration in KSA.