December 13, 2019
December 13, 2019 – The U.S. FDA has approved a new indication for Vascepa® (icosapent ethyl) capsules, manufactured by Amarin. The product is now indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in certain patients who have elevated triglyceride (TG) levels. The new indication applies to patients who have established cardiovascular disease, as well as patients who have diabetes mellitus and two or more additional risk factors for cardiovascular disease.
In a clinical study, patients taking Vascepa who met the above criteria experienced a 30% risk reduction in total major adverse cardiovascular events over five years compared to placebo. Major adverse cardiovascular events were defined as myocardial infarctions (heart attacks), strokes, coronary revascularizations, unstable angina requiring hospitalization, or cardiovascular death.
Recommended dosing is 4g per day with food, taken as either four 0.5g capsules twice daily or two 1g capsules twice daily. Patient’s lipid levels should be assessed before initiating therapy, and other causes of high triglyceride levels identified and managed as appropriate. Patients should engage in appropriate nutritional intake and exercise before receiving Vascepa, and these measures should continue during treatment.
Vascepa first received FDA approval in 2012 and is also indicated as an adjunct to diet to reduce TG levels in adult patients who have severe (≥ 500mg/dL) hypertriglyceridemia.
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.