Vascepa sNDA Seeking Expanded Indication to Reduce Major CV Events

Amarin has submitted a supplemental New Drug Application (sNDA) for Vascepa (icosapent ethyl) to reduce the risk of major cardiovascular (CV) events in the statin-treated population.

Icosapent ethyl is a single-molecule consisting of the omega-3 acid commonly known as EPA in ethyl-ester form. It is currently indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500mg/dL) hypertriglyceridemia.

The sNDA submission is based on data from the REDUCE-IT cardiovascular outcomes study, which assessed the outcomes of 8179 individuals who were administered icosapent ethyl therapy as an add-on to statins, and who had elevated triglyceride levels (≥135mg/dL). The primary endpoint was total composite CV death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or hospitalization for unstable angina.

The study results demonstrated that overall, icosapent ethyl reduced total primary endpoint events (61 vs 89 per 1000 patient years for icosapent ethyl vs placebo, respectively; relative risk [RR] 0.70, 95% CI 0.62-0.78, P <.0001). Vascepa showed a 25% relative risk reduction vs placebo in the first occurrence of a major adverse CV event (MACE) in the intent-to-treat population.

“The REDUCE-IT results support that approximately 1 fewer major cardiovascular adverse event would occur on average for every 6 patients treated with Vascepa for 5 years on top of statin therapy compared to placebo. This unprecedented result beyond cholesterol management presents an important new preventative care opportunity for millions of patients,” stated John F. Thero, president and chief executive officer of Amarin.

For more information visit Amarincorp.com.