The Saudi Food and Drug Authority (SFDA) has granted approval to Amarin’s VASCEPA (icosapent ethyl) capsules for reducing cardiovascular (CV) risk.
VASCEPA is indicated as an adjunct to statin therapy for use in adult patients with elevated levels of triglycerides (TG). This means levels greater than or equal to 150 mg/dL.
It has also been approved for use in patients at increased risk of CV events caused by at least one other CV disease risk factor and established CV disease, or who have diabetes mellitus.
The therapy is the first and only medicine to receive approval from the regulator to reduce CV risk beyond cholesterol-lowering therapy in patients on high-risk statin treatment and who have increased TG levels.
Amarin stated that the country’s National Heart Center (NHC) and the Saudi National Diabetes Center (SNDC) have mentioned icosapent ethyl (IPE) as an adjunct to statin therapy for CV risk reduction in their published guidelines for dyslipidemia and diabetes, under the Saudi Health Council (SHC).
The inclusion of IPE in the Saudi diabetes clinical practice guidelines (SDCPG)-2021 was based on the findings obtained from the REDUCE-IT trial.
Amarin chief scientific officer and research and development president Steven Ketchum stated: “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.
“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.”