EMA Accepts Amarin's Vascepa Marketing Authorization Application for Review

Posted on December 02, 2019 by Medtech[y] Staff

Amarin (NASDAQ: AMRN), announced today that the European Medicines Agency (EMA) has accepted the company's marketing application for icosapent ethyl (brand name Vascepa in the United States) as a treatment to reduce the risk of cardiovascular events in high-risk patients who have their cholesterol levels controlled with statin treatment but have elevated triglycerides.

With the EMA's acceptance, the validation confirms the submission for Vascepa is sufficiently complete for the EMA to begin its review procedure.

Amarin President and CEO, John Thero, commented on the news,“The prevalence in Europe of people with persistent cardiovascular risk beyond standard of care statin therapy is high, like it is in most of the world. This application moves us one step closer to being able to potentially help millions of high-risk patients with icosapent ethyl as studied in REDUCE-It.”

Thero added,“We seek to make icosapent ethyl accessible to as many patients as possible who can benefit. If marketing authorization is granted by the EMA, icosapent ethyl could become the first and only EMA-approved, non-LDL lowering agent with a cardiovascular disease risk reduction indication as an adjunct to statin therapy in dyslipidemic patients in Europe.”

In the US, Vascepa is currently approved as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.

In November 2019, an FDA advisory committee voted unanimously (16 – 0) to recommend to the FDA that Vascepa be approved for an indication and label expansion to reduce the risk of cardiovascular events in high-risk patients. While the FDA does not have to follow the committee's recommendation, historically they do take guidance from the Advisory Committee in making their decision. The decision by the FDA is anticipated on or before the FDA’s target Prescription Drug User Fee Act (PDUFA) date of December 28, 2019.

With the EMA application, Amarin is seeking a similar indication in Europe as they are in the US.

The expected expanded indication in the US is based on the REDUCE-IT study, which showed that Vascepa provided a 25% relative risk reduction compared to placebo in the first occurrence of a major adverse CV event (MACE) in the intent-to-treat population consisting of a composite of cardiovascular death, nonfatal myocardial infarction (MI or heart attack), nonfatal stroke, coronary revascularization (procedures such as stents and by-pass) and unstable angina requiring hospitalization.

The review is expected to be completed by the end of 2020.