- Results from the 8,179-subject REDUCE-IT study evaluating Amarin 's (NASDAQ:AMRN) Vascepa (icosapent ethyl) in statin-treated adults with elevated cardiovascular (CV) risk showed a significant treatment effect.
- The data were presented at the AHA Scientific Sessions in Chicago and simultaneously published in the New England Journal of Medicine.
- REDUCE-IT assessed 4 g/day of Vascepa over a median of 4.9 years. It achieved the primary endpoint of a statistically valid 25% (hazard ratio = 0.75) reduction in a composite of cardiovascular death, nonfatal heart attack, nonfatal stroke, coronary revascularization and unstable angina requiring hospitalization compared to statin therapy alone.
- Patients receiving Vascepa on top of statin therapy experienced 31% less risk of a heart attack, 35% less risk of urgent/emergent revascularization (stent or bypass surgery), 20% less risk of CV death, 32% less risk of hospitalization for unstable angina and 28% less risk of stroke. The risk of total mortality (CV and non-CV) was reduced 13%.
- The CV benefits did not appear to significantly influenced by triglyceride levels between 135 mg/dL and 499 mg/dL at baseline, the targeted patient population for the company's planned supplemental marketing application on tap for early 2019 [Vascepa is currently approved in the U.S. for patients with severe hypertriglyceridemia (at least 500 mg/dL)].
- The company emphasizes the low cost of Vascepa compared to alternatives, with a monthly copay of $9.99 or less and the cost of a 90-day supply for as little as $9, depending on the type of insurance coverage.
- Management says it is in the process of expanding its U.S. salesforce to over 400 headcount.
- Previously: Amarin reports positive results from REDUCE-IT study; shares up 307% premarket (Sept. 24)
- Now read: Amarin's REDUCE-IT Trial: Something Fishy?
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