All's Fair in Love, War, and FDA Decisions

All's Fair in Love, War, and FDA Decisions

Talk about throwing a Hail Mary.

Amarin has appealed the Food and Drug Administration's decision to rescind the Special Protocol Assessment, or SPA, it had with the biotech over an expanded indication for its lipid-lowering drug Vascepa.

Who does Amarin get to appeal to? A judge? A committee of outside experts? The President?

No, Amarin has to appeal to the FDA. With a decision as big as this, you don't think those making the decision talked to their bosses? It's not like SPAs are rescinded every day.

And then what?
Considering Amarin is fighting against the establishment that put it in this position, I'd say the likelihood of Amarin getting the SPA put back is somewhere between slim and none. But even if it is re-established, the SPA doesn't bind the agency into approving the drug.

The FDA clearly believes that there's no evidence that lowering triglyceride levels in patients with moderately high triglycerides has a clinical benefit. Of course, that was true when Amarin and the FDA established the SPA. The difference is that the hypothesis seemed reasonable a few years ago. Now, after multiple triglyceride-lowering drugs have failed to show an improvement in cardiovascular outcomes, the hypothesis appears less likely to be correct.

Amarin claims that the FDA shouldn't have focused the advisory committee -- which voted overwhelmingly against the expanded indication -- on the potential to reduce cardiovascular events because Amarin isn't asking for an expanded indication that includes reducing risk of cardiovascular disease. While it's true that Amarin only wants to claim that Vascepa reduces triglyceride levels, the FDA doesn't approve drugs for indications with surrogate endpoints unless it feels the surrogate endpoint is a reasonable proxy for a clinical endpoint. Otherwise, what's the point in taking the drug?

For instance, the FDA isn't convinced that raising good HDL cholesterol means anything clinically, which is why it made Merck run an outcomes trial before approving Cordaptive. Ironically, Merck's failed HPS2-THRIVE study was one of the clinical trial results the FDA cited as part of its argument to the committee since Cordaptive also lowers triglyceride levels.

Oh yeah, we sold some Vascepa
While much of Amarin's conference call was focused on how it's planning on fighting back against the FDA, Vascepa is still on the market for patients with very high triglyceride levels. Unfortunately, it's a small indication, and Vascepa hasn't picked up the off-label sales that GlaxoSmithKline's Lovaza has been able to capture. Despite being approved for essentially the same indication, Vascepa sales were just $8.4 million in the third quarter, compared to the $208 million in Lovaza sales that GlaxoSmithKline recorded.

The FDA's decision isn't fair, but Amarin needs to get over it and move on. It seems to me that focusing on improving sales of Vascepa would be a much better use of Amarin's time and energy than a fruitless appeal of the FDA's decisions.

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