Amarin announced Monday that a cardiovascular (CV) outcomes study of Vascepa (icosapent ethyl) in statin-treated adults with elevated CV risk met its primary endpoint, sending the company's shares up more than 300 percent. Top-line results of the REDUCE-IT trial showed that Vascepa demonstrated an approximately 25-percent relative risk reduction in major adverse CV events (MACE) in the intent-to-treat patient population compared to placebo.
The study, which started in 2011, enrolled 8179 adults with LDL-cholesterol controlled to between 41 mg/dL and 100 mg/dL by statin therapy and various CV risk factors including persistent elevated triglycerides between 150 mg/dL and 499 mg/dL, and either established CV disease or diabetes mellitus and at least one other CV risk factor. Subjects were randomised to receive either Vascepa dosed at 4 grams per day or placebo, with a median follow-up of 4.9 years.
Amarin noted that for the main goal, MACE included CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation or unstable angina requiring hospitalisation. The company noted that the primary endpoint was supported by "robust demonstrations of efficacy" across a number of secondary goals. Amarin added that Vascepa was well tolerated in the study, with the proportions of patients experiencing adverse events and serious adverse events similar between the two treatment groups.
According to Amarin, detailed results from the trial, which was conducted under a special protocol assessment agreement with the FDA, have been accepted for presentation at the Scientific Sessions of the American Heart Association (AHA) in November. CEO John Thero remarked "given Vascepa is affordably priced, orally administered and has a favourable safety profile, REDUCE-IT results could lead to a new paradigm in treatment to further reduce the significant cardiovascular risk that remains in millions of patients with LDL-C controlled by statin therapy."
Amarin indicated that it plans to work with its partners to support regulatory efforts outside the US based on the REDUCE-IT results. The company added that it is in the process of increasing the number of sales representatives promoting Vascepa to over 400 people in the US, whilst it has already boosted its inventory levels in preparation for positive results from the trial.
Vascepa was approved by the FDA in 2012 as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridaemia. However, the following year, an FDA advisory panel voted against expanded clearance to include use in conjunction with statin therapy to treat patients with mixed dyslipidaemia and triglyceride levels between 200 mg/dL and 499 mg/dL.
For related analysis, see ViewPoints: Amarin awaits its REDUCE-IT fate.
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