EddingPharm Secures China NMPA Approval for Vascepa

India Pharma Outlook Team | Wednesday, 10 July 2024

 pharmaceutical firm, cardiovascular health, India Pharma Outlook

Amarin Corporation plc, an innovative pharmaceutical firm, stated that its commercial partner in Mainland China (China), EddingPharm (Edding), has gained regulatory approval for Vascepa (icosapent ethyl) from the National Medical Products Administration (NMPA). Vascepa was approved by the NMPA for lowering the risk of cardiovascular events as an adjunct to statin therapy in adult patients with elevated and high triglycerides (=150mg/dL) and established cardiovascular disease or diabetes mellitus, as well as at least two other cardiovascular disease risk factors, combined with hypertriglyceridemia.

Following NMPA clearance, Edding is aiming to add Vascepa to the National Reimbursement Drug Listing (NRDL) and expand the ongoing commercial launch of Vascepa in China to include the CVRR indication. The NRDL is revised periodically and serves as the principal route for public reimbursement of pharmaceutical products in China, covering 98% of the population. Inclusion on the NRDL allows for full or partial reimbursement at the national level. Products on this list can be prescribed at public hospitals in China.

According to a recent assessment on cardiovascular health and disease in China, cardiovascular disease (CVD) accounted for 44-47% of all deaths in China's urban and rural areas, implying that CVD caused two of every five deaths. It is estimated that 330 million patients in China suffer from CVD, and the country has one of the highest CVD death rates in the world. According to the World Heart Federation, cardiovascular events such as ischemic heart disease and stroke are expected to increase by 50% in China between 2010 and 2030 (based only on population aging and growth).

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