Amarin CEO Discusses Vascepa's Expanded Labeling on CNBC

Posted on December 16, 2019 by Medtech[y] Staff

This past Friday, Amarin received FDA approval for a new indication and label expansion for VASCEPA (icosapent ethyl) capsules. With the approval VASCEPA is now the first and only drug approved by the FDA “as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease.”

With the big news, Amarin CEO, John Thero, joined CNBC today and discussed the approval and what it means for the future of the company.

“We at Amarin are excited and gratified to now have the opportunity to introduce VASCEPA as a new FDA-approved treatment option to reduce the persistent cardiovascular risk that many patients face despite use of statins with other contemporary standard-of-care therapies,” said John F. Thero, president and chief executive officer of Amarin. “We aim to help millions of high-risk patients, including statin-treated patients and statin-intolerant patients. For the first time, physicians, patients and payers have an FDA-approved treatment option beyond cholesterol lowering that has been demonstrated to significantly reduce major adverse cardiovascular events when used on top of a statin. We look forward to helping educate physicians and patients on the value of VASCEPA. The expanded indication and related clinical study labeling is broadly worded, informative on the many effects of VASCEPA and will empower physicians with critical information to help them apply their clinical judgment in addressing cardiovascular disease risk for patients in need.”

The next catalyst for Amarin will be patent litigation which should be resolved by the end of 2019 as well as Canadian approval. One of the bigger questions going forward will be if Amarin is going to go forge on alone or end up being acquired at some point in 2020.