2019-12-02| Trials & Approvals

Will Vascepa Receive a FDA Approval as a New Year Gift?

by Judy Ya-Hsuan Lin
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Amarin, a pharmaceutical company developing therapeutics to improve cardiovascular health, and its latest product Vascepa approaches an approval for expanding the application of the treatment of cardiovascular (CV) patients to a new preventive medication for potential CV individuals: the end of this year marks the FDA’s announcement. In tandem with statin drugs, Vascepa, an omega-3 fatty acid product containing purified EPA (omega-3 fat eicosapentaenoic acid) from fish oil, has already been approved to treat elevated triglyceride levels. Four main types of drug specifically target reducing blood cholesterol: statins (HMG-CoA reductase inhibitors), bile acid sequestrant resin, fabric-acid derivatives, and nicotinic acid. Amongst these four types, statin demonstrates the highest effectiveness for lowering cholesterol (by inhibiting the crucial enzyme that influences the rate of cholesterol synthesis in hepatic cells). However, its side effects include increased liver function index, headache, nausea and fatigue.

In order to extend Vascepa’s potential to reduce the risk of CV disease, Amarin launched its “Reduce-It” clinical trials, an extensive five-year study, to prove the ability of Vascepa plus statin therapy to treat and prevent CV better than mineral oil contained placebo plus statin therapy. Although most of the FDA’s committee members acknowledged Vascepa’s efficacy after several reviews and assessments, the results of Reduce-It still have the approval by the FDA retained due to three major concerns. First, the control group may be affected by the mineral oil used in placebo with statin. The mineral oil acts as a confounding factor in the clinical trials which leads to higher LDL (low-density lipoprotein) cholesterol deemed as a known heart risk factor. Because of this, the FDA suggests that the mineral oil must be excluded. Second, the final decision on whether or not to consider labeling language extending beyond patients with already established heart disease should be approved. In the future, the labeling language would include potential CV patients, not just the already diagnosed ones, if the FDA finally approves Vascepa’s extended use by end of this year.


Disputes & Concern to the Clinical Data from Reduce-It Clinical Trial Project

Reduce-It, an Amarin specific title, is a clinical trial lasting five years that studies more than 8000 patients at high risk of CV disease and who are already on statin therapy. Reduce-It grouped patients into two different treatments: one group is treated with mineral oil contained placebo plus statin therapy, serving as the control group, while the other group is treated with Vascepa plus statin therapy as the experimental group. The experimental set-up of Reduce-It by Amarin is aimed to testify a higher effectiveness of Vascepa plus statin therapy on treating both CV patients and potential CV patients than that of the control.

Reduce-It clinical trials have corroborated the efficacy of Vascepa reducing the risk of CV events by 25%, compared with placebo plus statin therapy; and yet, the FDA committee posted several concerns. “Vascepa posted a 31% relative risk reduction and 6.5% absolute risk reduction in the first occurrence of a major CV event, and a 30% relative and 2.6% absolute risk reduction in all-cause mortality in a specific subgroup,” according to the follow-up data to the original Reduce-It release in October 2018 by Amarin. The first major concern of a mineral oil in placebo with statin as a confounding factor to the Reduce-It clinical trial result is inconclusive and disputative among the FDA committee members. John Sharretts, acting deputy director of the FDA’s division of metabolism and endocrinology products, questioned whether “mineral oil interfered with patients’ ability to absorb statin therapy and artificially raised patients’ cholesterol levels.” In other words, Sharretts suspects that the mineral oil contained placebo plus statin therapy is less effective than Vascepa plus statin therapy owes to neither placebo nor statin; the mineral oil meddles with the statin’s treatment on CV disease. Sharretts implicates the absence of mineral oil as driving the efficacy of the placebo plus statin therapy. He seems to suggest the opposite of current assertions that Vascepa performs better than placebo because he implies that, without a mineral oil, the placebo may treat and prevent CV at a similar rate to Vascepa. Nevertheless, FDA staff commented in the briefing documents that “the median increase of 10~13% LDL cholesterol from baseline observed in the trial would increase CV risk by approximately 3%.” Importantly, “this small increase of risk appears numerically small and is unlikely to change the overall treatment effect direction.”

Apart from the different voices within the FDA concerned with mineral oil asy a confounding factor, two other issues on Vascepa consider whether Vascepa could be used beyond treatment of CV disease and Vascepa is safe enough to use as a preventative medicine on potential CV victims while risking the side effects of the drug. The FDA still doubts broadening the use of Vascepa because its approval will make a significant change to thousands of people’s lives as well as the market value of Amarin. The side effects of Vascepa are also one of the major issues concerning the FDA. The side effects of Vascepa include higher rate of atrial fibrillation or atrial flutter leading to hospitalization (3.1% versus 2.1% on placebo) and adverse events of bleeding (1.8% versus 9.9% on placebo). Is it worthwhile for the potential CV victims to become burdened with these risks? With all the uncertainties in mind, the end of this year will be met with a conclusive agreement by the FDA and a slew of interested people.




Edit By Judy Ya-Hsuan Lin


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