Amarin Corporation plc (ADR) (NASDAQ: AMRN)
A couple of months ago, we talked about how Amarin’s diet pill Vascepa possibly had heart health benefits. If you remember, the FDA was very clear about the fact that Amarin shouldn’t have announced that they have found their drug to provide heart benefits until approval was provided. Today, the FDA offered it’s CRL (Complete Response Letter). So today, we’ll talk about Vascepa and the benefits it’s believed to have, the FDA response, how AMRN reacted in the market, and what we can expect to see moving forward.
Amarin Wants To Change Vascepa Labeling
Vascepa is a medication provided by Amarin that’s currently approved for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. The new labeling that Amarin wanted to be approved for showed that Vascepa can be used as an adjunct to diet to reduce triglyceride levels in adult patients on statin therapy with mixed dyslipidemia and triglyceride levels.
How The FDA Responded To Amarin
All in all, the FDA denied the company’s request. They did acknowledge that Vascepa did prove to be effective in reducing triglyceride levels compared to a placebo. However, they also concluded that for regulatory approval, the company provided insufficient data proving that Vascepa did reduce cardiovascular risk in the ANCHOR population. As a result, Amarin will need to keep the current approved label on the medication until more testing is complete.
How The Market Reacted To The News
Amarin stock is down today. However, I’m not sure that the CRL is the only cause for the decline. The reality is that no matter where you look in the market right now, you’re going to see quite a bit of red. With that said, I’ll be diving into a reason for the market wide declines today. Nonetheless, AMRN is currently (11:37) trading at $2.09 per share after a decline of 2.80%.
What We Can Expect Moving Forward
One thing that we can’t discount is the fact that Amarin will continue to seek approval. The bottom line is that their testing did show that Vascepa has heart benefits; they simply didn’t prove without a reasonable doubt to the FDA that they’ve covered all bases. Although I hate to say this, it’s also possible that the FDA had a nasty taste about the drug already considering the early leak of information regarding the drug; even though a deal was made with the FDA that AMRN wouldn’t discuss results of the preliminary study.
With all of that said, I’m expecting more studies to be held and at some point, I’m expecting to see FDA approval for the new labeling of Vascepa. So, in the long run, we should see gains.
What Do You Think?
Where do you think AMRN is headed and why? Let us know in the comments below!