The China-based EOC Pharma Group has achieved a significant milestone with the National Medical Products Administration (NMPA) accepting its market filing for Vascepa (icosapent ethyl) for review. The drug is targeted for the prevention and reduction of cardiovascular event risks in adult patients with hypertriglyceridemia who are diagnosed with cardiovascular disease or diabetes with at least two other cardiovascular disease risk factors.
Indication and Usage
The indication for Vascepa, as proposed in the filing, includes the reduction of cardiovascular death, myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization. The drug is intended for use in combination with statins, providing an additional therapeutic option for patients who require further management of their triglyceride levels and cardiovascular risks.
Vascepa’s Origin and Licensing Deal
Vascepa, originally developed by US-based Amarin Co., plc (NASDAQ: AMRN), was first approved in the US in 2013 for reducing triglyceride levels in adult patients with severe hypertriglyceridemia (≥ 500 mg/dL). EOC Pharma Group secured a licensing deal with Amarin in 2015, acquiring development and commercialization rights for the drug in Greater China.
Regulatory Milestones and Market Expansion
The molecule became the first and only drug for high-risk patients with persistent cardiovascular risk after statin therapy in January 2020. It was introduced into the Boao Lecheng pilot zone one year later and subsequently earned approval in Hong Kong in March 2022. In Hong Kong, Vascepa is used alongside statins to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina caused by myocardial ischemia requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL), combined with diagnosed cardiovascular disease or diabetes and two or more other cardiovascular disease risk factors.- Flcube.com
