Vascepa capsules are the first-and-only prescription treatment approved by the FDA comprised solely of the active ingredient, icosapent ethyl, a unique form of eicosapentaenoic acid.
Shares of New Jersey-based Amarin Corporation are climbing in premarket trading following late Friday’s regulatory approval of its fish oil-based Vascepa, the first medication greenlit as an adjunct to maximally tolerated statin therapy to reduce cardiovascular risk.
Cardiovascular disease is one of the most common in the United States. Cardiovascular events, which include heart attack, stroke and cardiovascular death, occur at a rate of every 14 seconds in the United States. With such a need, Amarin suggests that the newly-approved Vascepa will benefit millions of at-risk patients in the U.S. Vascepa is now the only U.S. Food and Drug Administration-approved medication 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 and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease.
Vascepa (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the FDA comprised solely of the active ingredient, icosapent ethyl, a unique form of eicosapentaenoic acid. Friday’s approval was based on the results of the REDUCE-IT trial that showed a 28% risk reduction in the first occurrence of major adverse cardiovascular events (MACE) in the intent-to-treat population. As evidenced by this MACE occurrence, there is a group of patients who, despite controlling their cholesterol on statin therapy, continue to have a high need for additional preventative cardiovascular care, Amarin said. Following the announcement of the REDUCE-IT data in late 2018, Amarin signaled its intentions to seek regulatory approval for this indication and then last month, it received unanimous support from an FDA advisory committee.
Deepak L. Bhatt, executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and lead investigator of the REDUCE-IT study, called the approval a “major milestone” in cardiovascular prevention.
“Nothing this significant has happened in the world of cardiovascular prevention since the introduction of statins nearly three decades ago. Many patients stand to benefit from this historic advance in care,” Bhatt said in a statement.
John F. Thero, president and chief executive officer of Amarin, touted the potential Vascepa has in treating patients across the United States.
“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,” Thero said in a statement.
Vascepa was previously approved as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia
With the approval, Amarin said it intends to “promptly launch” Vascepa in the United States. In preparation for the approval, Amarin began to double the size of its sales force this year and, according to the company, is on track to double the size of its sales force again to a total of 800 sales representatives near the beginning of 2020.
Following the approval, Amarin updated its revenue guidance for 219 and 2020. For 2019, Amarin said it increases its guidance for total net revenue to a range of $410 to $425 million. With respect to 2020, Amarin projects that total net revenue will be in a range of $650 to $700 million, mostly from sales of Vascepa in the United States.
