Amarin Corporation plc (NASDAQ: AMRN) is having a great start to the trading session this morning, and for good reason. As I’ve been pointing to in recent posts, the company’s sNDA for Vascepa was the topic of a recent advisory committee meeting at the FDA. Late yesterday, the company reported a positive vote from the meeting. Here’s what’s going on:
AMRN Stock Heads Up On Positive Advisory Committee Results
In a press release issued late yesterday, Amarin Corporation announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA has voted for approval of the company’s sNDA. The vote was unanimous, with all 16 members of the committee voting in favor of approval.
At the moment, AMRN is working to expand the label of Vascepa to include an indication to reduce risk of cardiovascular events in high-risk patients. The application is supported by the REDUCE-IT cardiovascular outcomes trial.
While advisory committees do not have the ability to approve or reject a drug, their opinion is held in high regard by the FDA. In fact, in my history covering various stories in the biotech space, I have never seen a landslide vote for approval from an advisory committeee meeting that did not lead to approval. Sure, it has likely happened in the past, but in my years of experience, I haven’t seen it.
In a statement, John F. Thero, President and CEO at AMRN, had the following to offer:
Today we moved an important step closer to potentially helping millions of patients who are at risk for cardiovascular events despite being on standard-of-care statin therapy. Vascepa is positioned to be the first approved treatment to reduce cardiovascular events in the group of at-risk patients studied in the landmark REDUCE-IT clinical trial. We appreciate both the opportunity to present these results and the committee’s strong vote of confidence. We look forward to anticipated labeling discussions with the FDA, and we continue to prepare for the launch of Vascepa assuming FDA approval of our sNDA on or before the target PDUFA date of December 28.
Why Investors Are So Excited
There are a few very good reasons that investors are excited about Amarin Corporation stock today. Here’s how I see it:
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