Amarin Corporation Receives Saudi Food and Drug Authority Approval for VASCEPA®
Thursday, June 22, 2023
Amarin Corporation and its commercialisation partner, Biologix, have recently announced that the Saudi Food and Drug Authority (SFDA) has granted approval for a new indication and label expansion for VASCEPA® (icosapent ethyl) capsules.
VASCEPA has recently become the first and only drug to receive approval from the SFDA as a complement to statin therapy for adult patients who have elevated triglyceride (TG) levels (≥150 mg/dL). This approval is specifically for individuals at high risk of cardiovascular (CV) events due to pre-existing cardiovascular disease or diabetes mellitus, along with at least one additional risk factor for cardiovascular disease.
This approval signifies a significant milestone in expanding the global reach of VASCEPA/VAZKEPA, as it is now authorised for cardiovascular risk reduction based on the promising outcomes observed in the REDUCE-IT outcomes trial.
