European Medicines Agency (EMA) accepts New Drug Application for omega-fatty acid therapy, Vascepa (icosapent ethyl) -

European Medicines Agency (EMA) accepts New Drug Application for omega-fatty acid therapy, Vascepa (icosapent ethyl)
Information type: Media and commentaries
Source: PharmaTimes
Specialities: Cardiovascular system disorders | Nutritional and metabolic disorders
Summary
EMA expects to complete review by the end of 2020, for the indication of reducing the risk of cardiovascular (CV) events in high-risk patients who have their cholesterol levels controlled with statins, but have elevated triglycerides and other CV risk factors.
UKMi comment
Of note, NICE do not recommend omega‑3 fatty acid compounds for preventing CVD. Other omega- fatty acid therapies licensed in the EU e.g. Omacor (omega-3-acid ethyl esters 90) 1000 mg Soft Capsules; are licensed only as adjuvant treatment in secondary prevention after myocardial infarction or for treatment of hypertriglyceridaemia.
Related links: NICE guideline