Amarin announces enrollment of the REDUCE-IT cardiovascular outcomes study surpasses 6,000 patients
Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the number of patients enrolled in the company's REDUCE-IT cardiovascular outcomes study of Vascepa(R) (icosapent ethyl) capsules has surpassed 6,000.
The REDUCE-IT (Reduction of Cardiovascular Events with EPA - Intervention Trial) study is a multinational, prospective, randomized, double-blind, placebo-controlled, parallel-group study taking place at over 400 clinical sites in 11 countries to evaluate the effectiveness and safety of Vascepa(R) (icosapent ethyl) capsules, as an adjunct to optimized statin therapy, in reducing the incidence of first major cardiovascular events in a patient population at high risk for such events. The control arm of the study consists of patients on optimized statin therapy plus placebo. The active arm of the study consists of patients on optimized statin therapy plus Vascepa 4g/day. The high-risk patient population in REDUCE-IT has both a mean and median baseline triglyceride (TG) level over 200 mg/dL, a level substantially above those from recently conducted outcomes trials of other prescription lipid modifying therapies. Furthermore, Amarin has taken steps to ensure that the final baseline TG levels remain above 200 mg/dL. In addition, all patients enrolled in the study have either documented cardiovascular disease (CVD) or are at high-risk for CVD.
The REDUCE-IT study is being conducted under Amarin's previously announced Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). An SPA agreement is an agreement with the FDA that the Phase 3 trial protocol design, clinical endpoints, and planned statistical analyses are acceptable to support regulatory approval. An SPA agreement is generally considered binding upon the FDA unless public health concerns unrecognized at the time of protocol assessment are evident.
"Reaching the 6,000 patient mark in the REDUCE-IT trial represents significant progress toward full enrollment and another significant highlight for Amarin in 2013," said Joseph Zakrzewski, Amarin's Chairman and CEO. "The results of REDUCE-IT may enable us to seek additional indications for Vascepa including cardiovascular risk reduction, which would represent a patient population estimated to be almost twice that of the combined indications studied in the MARINE and ANCHOR trials or approximately 70 million adults in the United States alone."
About Vascepa(R) (icosapent ethyl) capsules
Vascepa(R) (icosapent ethyl) capsules, known in scientific literature as AMR101, is a patented, pure-EPA omega-3 prescription product in a 1 gram capsule.
Indications and Usage
-- Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce
triglyceride (TG) levels in adult patients with severe ( greater than or
equal to 500 mg/dL) hypertriglyceridemia.
-- The effect of Vascepa on the risk for pancreatitis and cardiovascular
mortality and morbidity in patients with severe hypertriglyceridemia has
not been determined.
Important Safety Information for Vascepa
-- Vascepa is contraindicated in patients with known hypersensitivity
(e.g., anaphylactic reaction) to Vascepa or any of its components and
should be used with caution in patients with known hypersensitivity to
fish and/or shellfish.
-- The most common reported adverse reaction (incidence > 2% and greater
than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo).
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM
Vascepa is under various stages of development for potential use in indications that have not been approved by the FDA, such as the potential indications that are under development in the REDUCE-IT trial. Nothing in this press release should be construed as promoting the use of Vascepa in any indication that has not been approved by the FDA.