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 am presently taking Vascepa because it does not raise LDL and it reduces inflammation. This is important because I have a stent in heart. I also take a statin but as you well know statins also reduce HDL's. From all the reading I've done regarding inflammation and it's effects on heart health, Vascepa in my opinion is a wonder drug. Pure EPA is without a doubt going to prove to be a very effective drug with no side effects. I'm looking forward to getting my blood work results. I'm certain they will be a pleasant surprise.

Edward Distefano
Watertown, Connecticut
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