The Food and Drug Administration (FDA)’s Endocrinologic and Metabolic Drugs Advisory Committee voted in favor (16-0) to recommend the approval of Vascepa (icosapent ethyl capsules; Amarin) to reduce residual cardiovascular (CV) risk in patients with statin-managed low density lipoprotein (LDL) cholesterol, but persistent elevated triglycerides.

The application included data from the REDUCE-IT trial that 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 end point) when compared with placebo (95% CI, 0.68-0.83; P<.001).

In addition, the Company recently announced prespecified subgroup analyses from REDUCE-IT that included 3146 US patients. Results from this analysis showed that treatment with Vascepa led to a 31% relative risk reduction and 6.5% absolute risk reduction in first occurrence of 5-point MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, or hospitalization for unstable angina).

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“The REDUCE-IT results are quite remarkable and illustrate how icosapent ethyl could transform the treatment of cardiovascular disease in the United States and worldwide,” said Deepak L. Bhatt, MD, MPH, executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital Heart and Vascular Center, and professor of medicine at Harvard Medical School. “From my perspective as not only a researcher but also a practicing physician, icosapent ethyl represents one of the most important developments in the prevention and treatment of cardiovascular disease since statins and, if FDA approved, will be a critical tool for physicians to use to help prevent cardiovascular events such as heart attack and stroke, including fatal ones, in high-risk patients.”

Although not bound by the committees’ recommendations, the FDA does take them into consideration when making decisions on approval. A Prescription Drug User Fee Act (PDUFA) date of December 28, 2019 has been assigned for the application.

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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