The EPA
Drug Initiative

Make your voice heard, urge the FDA to approve Vascepa for mixed dyslipidemia

Consumer Group Challenges FDA to Abide by Its Own Guidelines

Urges Reinstatement of SPA for Heart Drug Vascepa

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.

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I've been taking Vascepa for 5 months and I can report the results have been excellent. My triglycerides went from 440 mg/dL to under 190 mg/dL. I've also noticed another benefit besides lower Triglycerides which is less eye inflammation. I've suffered from Dry Eye Syndrome for over 30 year and since taking Vascepa my eyes are much improved and I haven't had the need for eye drops.

John Cappello
Middlebury, CT
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