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Results from the 8,179-subject REDUCE-IT study evaluation 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 New England Journal of Medicine.
REDUCED 4 g / day of Vascepa over a median of 4.9 years. In the 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 the statin therapy experienced, the lowest risk of a heart attack, 20% 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 by 13%.
The CV benefits did not appear to be significantly affected by triglyceride levels between 135 mg / dL and 499 mg / dL at baseline, the targeted patient population for the company is 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 cost of a $ 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)
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