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May 29, 2019

FDA Grants Priority Review for Supplemental NDA for a Cardiovascular Risk Reduction Indication for Amarin's Vascepa

May 29, 2019—Amarin Corporation plc announced that its supplemental new drug application (sNDA) for Vascepav (icosapent ethyl) capsules has been accepted for filing and granted Priority Review designation by the FDA. The FDA assigned a Prescription Drug User Fee Act goal date for the sNDA of September 28, 2019, which is approximately 4 months earlier under Priority Review than the anticipated standard 10-month review for applications.

If approved, Vascepa will be indicated to reduce residual cardiovascular risk in patients with statin-managed low-density lipoprotein cholesterol (LDL-C), but persistently elevated triglycerides. Vascepa is currently indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (TG > 500 mg/dL) hypertriglyceridemia.

According to the company, the sNDA for Vascepa is based on the landmark REDUCE-IT cardiovascular outcomes study.

Deepak L. Bhatt, MD, who is Global Principal Investigator and Steering Committee Chair for REDUCE-IT, presented the study's primary results at the American Heart Association's 2018 Scientific Sessions held November 10–12 in Chicago, Illinois. The results were simultaneously published online by Dr. Bhatt, MD, et al in The New England Journal of Medicine (2019;380:11–22). In March, additional results and analysis of total recurrent events observed were published by Fabien Picard, MD, et al in Journal of American College of Cardiology (2019;73:1362-1364).

The company advised that in REDUCE-IT, Vascepa achieved the primary endpoint with a 25% relative risk reduction compared with placebo (95% confidence interval [CI], 0.68–0.83; P < .001) in the first occurrence of a major adverse cardiovascular event (MACE; a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, and unstable angina requiring hospitalization) in the intent-to-treat population. Additionally, Vascepa achieved the study’s key secondary endpoint with a 26% relative risk reduction (hazard ratio, 0.74; 95% CI, 0.65–0.83; P < .001) in three-point MACE in the intent-to-treat population consisting of a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, noted Amarin.

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