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 personally take Vascepa off label because of it's anti-inflammatory effects as proven by the significant reduction in hs-CRP in clinical trials. The correlation between inflammation and CVD is well established the the medical literature. In my opinion, it would be a travesty to not allow Vascepa to be marketed for the ANCHOR indication of TG's >200 until after the results of the REDUCE-IT trial. Real people's lives and health are at stake here, not just numbers. Many people will benefit from this drug. Thank you.

Terence Gallagher
Haverford, Pennsylvania
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