The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for Vascepa (icosapent ethyl; Amarin) to reduce residual cardiovascular (CV) risk in patients with statin-managed LDL-C cholesterol, but persistent elevated triglycerides.
The sNDA includes data from the REDUCE-IT trial which assessed the cardiovascular outcomes of 8179 patients who were administered Vascepa as an add-on to statins, and who had elevated triglyceride levels (≥135mg/dL). Treatment with Vascepa resulted in a 25% relative risk reduction in the first occurrence of a major adverse CV event (MACE) in the intent-to-treat population (primary endpoint) when compared with placebo (95% CI, 0.68-0.83; P<.001).
“We expect earlier approval of an expanded indication for Vascepa to lead to faster improvements in care for millions of patients with residual cardiovascular risk after statin therapy,” said John F. Thero, president and chief executive officer of Amarin. “These patients will be the focus of our planned expanded REDUCE-IT promotional efforts.”
A Prescription Drug User Fee Act (PDUFA) date of September 28, 2019 has been assigned by the FDA for this sNDA. If approved, Vascepa would be the first drug approved for this indication.
Vascepa is currently indicated for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500mg/dL) hypertriglyceridemia.
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