China Approves VASCEPA® for Cardiovascular Risk Reduction

Amarin Corporation PLC has announced that its commercial partner, EddingPharm (EDDING), received approval from China’s National Medical Products Administration (NMPA) for VASCEPA® (icosapent ethyl). This approval allows the drug to be used as an adjunct therapy to statins in adult patients with high triglyceride levels (≥150 mg/dL) and other high-risk cardiovascular conditions, as studied in the REDUCE-IT trial.

Following this regulatory approval, EDDING is actively working to have VASCEPA included in China’s National Reimbursement Drug Listing (NRDL). The NRDL is updated annually and is crucial for public reimbursement of pharmaceutical products, covering 98% of China's population. Inclusion in the NRDL ensures that medications can be prescribed and reimbursed through public hospitals across the country.

Cardiovascular disease (CVD) is a significant health issue in China, responsible for 44-47% of all deaths in urban and rural areas, with an estimated 330 million patients suffering from CVD. According to projections by the World Heart Federation, cardiovascular events, such as ischemic heart disease and stroke, are anticipated to rise by 50% in China from 2010 to 2030 due to aging and population growth.

Steven Ketchum, Ph.D., President of Research & Development and Chief Scientific Officer at Amarin, hailed the approval as a critical advancement in widening access to VASCEPA for patients in China. He emphasized that this milestone would help ensure that the unique benefits of VASCEPA are available to patients globally. EDDING also expressed optimism, highlighting that the approval will enable many Chinese patients with atherosclerotic cardiovascular disease (ASCVD) to benefit from this innovative treatment. The company plans to further expand the use of VASCEPA in managing cardiovascular diseases to address the unmet clinical needs of more patients.

As part of the regulatory requirements, NMPA has mandated that EDDING conduct a post-approval study to confirm the drug's efficacy in reducing cardiovascular events among Chinese patients. EDDING will have to submit a study report for a lifecycle benefit-risk assessment five years post-approval.

Under the agreement between Amarin and EDDING, the latter is responsible for the development and commercialization of VASCEPA in China, bearing the associated expenses. Amarin provides development support and supplies the finished bulk product. Following the NMPA's approval, Amarin will receive a regulatory milestone payment of $15 million. Additionally, EDDING will pay Amarin tiered double-digit percentage royalties based on net sales of VASCEPA within the territory. The product supply to EDDING will be under negotiated terms.

Amarin is a pioneering pharmaceutical company focused on cardiovascular disease management, aiming to advance scientific understanding and treatment options for persistent cardiovascular risk beyond traditional therapies. The company has offices in various locations, including the United States, Ireland, and Switzerland, and collaborates with commercial partners and suppliers worldwide.

VASCEPA is the first prescription treatment approved by the U.S. FDA that contains only the active ingredient icosapent ethyl. It was initially launched in the United States in 2013 to reduce triglyceride levels in adults with severe hypertriglyceridemia. In January 2020, it received FDA approval to treat high-risk patients with persistent cardiovascular risk after statin therapy. Since its launch, VASCEPA has been prescribed over 20 million times and is covered by most major insurance plans. Alongside the United States, icosapent ethyl is approved and marketed in Canada, Lebanon, the UAE, and several European countries under the brand name VAZKEPA.

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