Amarin Leverages 25M Prescriptions and 59-Country License to Boost VASCEPA Growth
Amarin commented on innovations in elevated triglyceride therapies, noting that its VASCEPA/VAZKEPA franchise, prescribed over 25 million times globally, is well-positioned for payor-driven step-therapy uptake for severe hypertriglyceridemia (TG≥500 mg/dL). It also secured a long-term license to commercialize VAZKEPA in 59 European countries through 2039, expanding its global reach.
1. Breakthrough Therapies Poised to Drive Triglyceride Category Growth
Amarin highlighted recent approvals of ApoC-III–targeted injectables and other novel agents for patients with severe hypertriglyceridemia (TG ≥500 mg/dL) and rare genetic disorders such as familial chylomicronemia syndrome. The company noted that these innovations are elevating physician awareness of high-risk patient populations—estimated at more than 1.5 million in the U.S. alone—and are expected to broaden overall triglyceride treatment protocols over the next five years. As new therapies enter practice, Amarin expects increased demand for well-established oral options, with VASCEPA/VAZKEPA positioned as a proven first-line step in payor protocols.
2. VASCEPA/VAZKEPA Demonstrates Robust Cardiovascular Outcomes
Drawing on data from the landmark REDUCE-IT outcomes trial (8,179 patients), Amarin underscored that adjunctive icosapent ethyl therapy achieved a 25% relative reduction in major adverse cardiovascular events versus placebo when added to statin regimens in patients with elevated triglycerides (≥150 mg/dL). In the pivotal MARINE study, approximately 50% of patients treated with 4 g/day icosapent ethyl achieved triglyceride levels below 500 mg/dL after 12 weeks, with no associated rise in LDL-C. These results reinforce the safety and efficacy profile of VASCEPA/VAZKEPA and differentiate it from both older fibrates and newer injectable agents yet to demonstrate cardiovascular benefit.
3. Expanding Global Footprint Through Strategic Licensing
In 2025, Amarin secured an exclusive long-term license and supply agreement with Recordati S.p.A. to commercialize icosapent ethyl across 59 territories in Europe, where patent protection extends through 2039. The franchise is already commercially available in more than 20 countries, including Canada, China, Australia and several Gulf Cooperation Council states. This collaboration leverages Recordati’s established distribution network to target a combined addressable market exceeding 60 million patients at high cardiovascular risk in Europe alone.
4. Payor-Driven Step-Therapy Programs to Accelerate Uptake
U.S. and select international payors have implemented step-therapy requirements that designate VASCEPA/VAZKEPA as a preferred first-line therapy prior to coverage of newer, higher-cost injectable alternatives. Drawing parallels to the post-2015 experience with PCSK9 inhibitors—where step-therapy drove sustained annual prescription growth of roughly 15% for ezetimibe—Amarin projects that broadened indications and expanding patient labels for ApoC-III agents will further funnel utilization toward its oral franchise, enhancing volume growth and leverage across markets.