Pharma Focus Asia

Amarin Partner EddingPharm Secures Approval for VASCEPA® (Icosapent Ethyl) in Mainland China to Reduce Cardiovascular Risk

Tuesday, July 09, 2024

Amarin Corporation plc (NASDAQ: AMRN) has announced that its partner in Mainland China, EddingPharm (EDDING), has received regulatory approval from China’s National Medical Products Administration (NMPA) for VASCEPA® (icosapent ethyl). This approval allows VASCEPA to be used alongside statin therapy to reduce cardiovascular events in adult patients with high triglycerides (≥150 mg/dL), established cardiovascular disease, or diabetes mellitus with additional cardiovascular risk factors.

Following NMPA approval, EddingPharm aims to include VASCEPA on China's National Reimbursement Drug Listing (NRDL) to enable broader public reimbursement across the country. The NRDL covers a vast majority of the population and is crucial for access to pharmaceutical products in public hospitals.

Cardiovascular disease is a significant health issue in China, responsible for a substantial portion of deaths nationwide. With an estimated 330 million patients affected by cardiovascular disease, the approval of VASCEPA is seen as a pivotal step in addressing the country's high cardiovascular disease burden. The approval includes a requirement for EddingPharm to conduct a post-approval study to further assess VASCEPA's effectiveness in reducing cardiovascular events in Chinese patients.

Under their partnership agreement, Amarin will receive a $15 million regulatory milestone payment from EddingPharm upon approval, along with tiered royalties on net sales of VASCEPA in China. Amarin will supply the finished product to EddingPharm as per negotiated terms.

VASCEPA, originally approved in the U.S. and subsequently in other regions, is notable for being the first and only drug approved by the FDA for reducing cardiovascular risk in high-risk patients with elevated triglycerides despite statin therapy. It has been prescribed over 20 million times in the U.S. and is covered by major medical insurance plans.



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