BEDMINSTER, NJ (TheStreet) -- The FDA advisory panel convening Wednesday will focus on whether or not to recommend the expanded use of Amarin's ( (AMRN)) prescription fish-oil pill Vascepa. There's also a larger and more important issue at stake: Should the FDA approve cardiovascular drugs based solely on surrogate endpoints, or hold off approval until these drugs are proven to reduce the risk of heart attacks, strokes and death?
Let's preview Amarin's all-important Vascepa FDA panel:
Adam, clear something up for me before we get into the meat of the Vascepa debate. What the hell is "mixed dyslipidemia" and why is it so important to Amarin?
With respect to Amarin, a person with mixed dyslipidemia is taking a cholesterol-lowering statin to lower LDL or "bad" cholesterol but still has moderately elevated levels of triglycerides, a fatty substance found in blood. People with mixed dyslipidemia are believed to be at higher risk for cardiovascular disease.
Last year, FDA approved Vascepa to lower triglycerides in patients with severe hypertriglyceridemia, defined as super high triglyceride blood levels greater than 500 mg/dl. Now, Amarin wants FDA to approve an expanded use of Vascepa to treat these mixed dyslipidemia patients.
Expanding the FDA-approved use of Vascepa is important to Amarin because approximately 21% of Americans have mixed dyslipidemia. Amarin has not done a very good job selling Vascepa today so it hopes to turn the drug's fortunes around by broadening its FDA-approved label.
Amarin and its supporters talk about the "Anchor" patient population? What do they mean?
"Anchor" was the acronym used by Amarin to describe the phase III clinical trial of Vascepa in patients with mixed dyslipidemia. When you hear someone talk about "Anchor" think mixed dyslipidemia.
Amarin apparently likes nautical imagery because the company's first phase III study used for the initial Vascepa approval was dubbed "Marine."
Was the "Anchor" study positive?
Yes it was, and for the most part, the efficacy and safety of Vascepa, as defined in the "Anchor" study, are not going to be a point of contention or debate during at Wednesday's FDA advisory panel.
In the "Anchor" study, 12 weeks of Vascepa dosed at 4 mg/day lowered triglycerides levels by a median 17.5% compared to a median 5.9% increase for patients treated with a placebo. This Vascepa reduction in triglyceride levels, relative to placebo, met the primary endpoint of the "Anchor" study. Beneficial changes in other lipids levels also favored Vascepa, and no significant adverse events or toxicities associated with the drug were reported.
Ha! Adam, you're such a trickster. This is where you tell me about the red flags in the "Anchor" study and why Amarin is hiding reams of negative Vascepa data. C'mon, stop playing games.
Nope. Amarin isn't hiding any negative data. Vascepa is prescription-grade fish oil designed to lower triglyceride levels. That's what the drug did in the "Anchor" study. FDA isn't disputing Vascepa's ability to lower triglycerides. Well, FDA does bring up an issue with the mineral oil used as a placebo in the "Anchor" study, but let's not go there quite yet.
I'm confused. If the "Anchor" study results aren't up for debate, why is FDA holding this advisory panel on Wednesday?
Ah! Time to dig into the meat of the Vascepa debate. The FDA explains the issue best in the review of Vascepa posted to the agency's web site on Friday afternoon: