RegulatoryJun 30, 2026, 04:17 PM
Amarin Applauds FDA Approval of APOC3 Therapies, Highlights VASCEPA Value
AI Summary
Amarin Corporation acknowledged the recent FDA approval of injectable apolipoprotein C-III (APOC3) therapies for severe hypertriglyceridemia (sHTG), recognizing their therapeutic advancement. However, the company emphasized the continued clinical and economic value of its foundational therapy, VASCEPA, for a broad segment of patients. Amarin highlighted VASCEPA's robust triglyceride reductions, lower cost compared to new therapies, proven efficacy in reducing cardiovascular events, and broad guideline support.
Key Highlights
- FDA approved injectable APOC3 therapies for severe hypertriglyceridemia (TG >= 500 mg/dL).
- VASCEPA delivers a 33% median reduction in TG levels in sHTG patients.
- Approximately 50% of sHTG patients achieve TG levels below 500 mg/dL with VASCEPA.
- New injectable APOC3 therapies have an annual wholesale acquisition cost (WAC) of $40,000.
- VASCEPA's annual wholesale acquisition cost (WAC) is approximately $4,200 per patient.
- VASCEPA reduces cardiovascular events by 25% when added to a statin in high-risk patients.
- VASCEPA has been prescribed more than 30 million times globally.
Price Impact
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