Amarin Corporation plc (NASDAQ:AMRN) reported Food and Drug Administration approval of VASCEPA to reduce cardiovascular risk. The company said it expects 2019 VASCEPA net revenue of $410 million to $425 million and 2020 VASCEPA net revenue of $650 million to $700 million.
Amarin, with headquarters in Dublin and Bridgewater, New Jersey announced Friday that,. after more than a decade of development and testing, 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.”
It is estimated that millions of high-risk patients in the United States could benefit from this one-of-a-kind prescription therapy.
CEO John F. Thero said “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”
Amarin reinforced its intention to promptly launch VASCEPA in the United States for this important new preventative care indication. As previously disclosed, Amarin doubled the size of its sales force near the beginning of 2019 and is on track to double the size of its sales force again to a total of 800 sales representatives near the beginning of 2020
AMRN shares gained 17 cents to $24.29