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SOURCE The EPA Drug Initiative
Urges Reinstatement of SPA for Heart Drug Vascepa
NEW YORK, Feb. 4, 2014 /PRNewswire-USNewswire/ -- The EPA Drug Initiative (EPADI) asserts that the FDA did not live up to its own scientific integrity standards in rescinding the Special Protocol Assessment (SPA) related to the "ANCHOR" sNDA for the triglyceride (TG) lowering drug, Vascepa, and urges that the Agency adhere to its own policies in the appeal of the SPA rescission decision.
Specifically, EPADI believes that in drawing conclusions from three other failed triglyceride-lowering studies (ACCORD-Lipid, AIM HIGH and HPS2 THRIVE) – each of which involved drugs, objectives/endpoints and patient characteristics different from those in the ANCHOR study – the Agency's integrity has been compromised severely.
Consistent with the Agency's own Staff Manual Guide issued on February 3, 2012 (SMG 9001.1), EPADI urges the FDA to strictly adhere to its own stated policy of placing scientific integrity at the forefront of its mission.
The first key principle of scientific integrity listed in this guide states "Maintaining a firm commitment to science-based, data-driven decision-making." Maintaining scientific integrity is especially important given the very high legal threshold required to rescind a SPA. EPADI believes the Agency has not lived up to this policy commitment, in that:
The Agency has the opportunity to re-evaluate the data from these studies under the appeal currently underway.
A second key principle of SMG9001.1, "Shielding the Agency's science and its scientific staff from political influence", should be taken into account relative to the competitive landscape for Vascepa's parent company, Amarin Corp. Amarin is a much smaller company than the large pharmaceutical companies whose drugs would compete with Vascepa. Large pharmaceutical companies are constantly accused of attempting to influence FDA decision-making. EPADI hopes this has not occurred during the FDA's review of Vascepa and urges senior Agency officials to be sure this policy has indeed been vigorously enforced.
We contend that denying patients on background statin therapy the proven and safe TG and LDL-C lowering effects of Vascepa makes absolutely no sense given the epidemic nature of heart disease, the associated costs and toll in terms of human suffering, and the undesirable side effect profile associated with statin therapy. Furthermore, while statins have been shown to reduce CV risk, patients on such therapies continue to have significant residual risk of a repeat event, such as a heart attack.
The American Heart Association acknowledges that the amount of triglycerides (or blood fats) in the blood is an important indicator of metabolic health; high TG levels are associated with coronary heart disease, diabetes and fatty liver disease.
Vascepa has demonstrated a remarkable efficacy in lowering TG levels. In ANCHOR, the largest trial ever conducted of an Omega-3 therapy in patients with high TGs on background statin therapy, a 4-gram dose of Vascepa was shown to reduce TG levels by over 21% (p < .0001). Significant LDL-C reduction of > 6% was also achieved. No other Omega-3 therapy has been shown to reduce TGs without raising LDL-C. ANCHOR also statistically demonstrated significant decreases in all predefined secondary endpoints, including: Non-HDL-C, Apo B, Lp-PLA2 and VLDL-cholesterol. Of the 702 patients enrolled in ANCHOR, 73% were diabetic. The side effect profile for Vascepa was similar to placebo, making it the safest of all TG lowering agents.
The full FDA Staff Manual Guide on scientific integrity (SMG 9001.1) can be found at: http://www.fda.gov/aboutfda/reportsmanualsforms/staffmanualguides/ucm289975.htm
In closing, the EPADI urges Drs. Margaret Hamburg, FDA Commissioner; Stephen Ostroff, FDA Chief Scientific Officer; Janet Woodcock, FDA Director of the Center for Drug Evaluation and Research; and Dr. Curtis Rosebraugh, FDA Director for Drug Evaluation II, to carefully review the Agency's SPA rescission argument to determine whether it fully and conscientiously adheres to all policies issued in SMG 9001.1 on scientific integrity.
About The EPA Drug Initiative:
The EPA Drug Initiative is a group of physicians, patients and concerned citizens, who are bound by a common objective to encourage the Food and Drug Administration to approve Vascepa for the expanded label indication of treating high triglycerides. Members of EPADI share a common view that the highly purified form of EPA, as only found in Vascepa, offers significant therapeutic value in treating cardiovascular disease. http://epadruginitiative.com
We currently have sponsored two important petitions:
The Citizen's Petitions from many members of EPADI, relative to the FDA's Vascepa SPA rescission decision (Docket number FDA-2013-P-1612), can be found at: http://www.regulations.gov/#!docketDetail;D=FDA-2013-P-1612
An online petition urging the FDA to approve Vascepa for high triglycerides/mixed dyslipidemia can be found here: http://www.thepetitionsite.com/176/817/515/urge-the-fda-to-approve-vascepa-for-mixed-dyslipidemia
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