What happened
Shares of Amarin (AMRN -0.53%) are down by a whopping 16.7% as of 12:03 p.m. EDT on Friday. The drugmaker's stock is getting pummeled in response to the news that the Food and Drug Administration (FDA) has indeed decided to convene an advisory committee meeting to discuss the company's proposed label expansion for the prescription omega-3 pill Vascepa.
Image source: Getty Images.
So what
Last week, Amarin's management noted that an advisory committee meeting was no longer likely in its view, given that the drug's Prescription Drug User Fee Act (PDUFA) goal date of Sept. 28 was less than two months away. So it's not entirely surprising that some investors are heading for the exits in the wake of this unexpected regulatory update.
Now what
Vascepa's advisory committee meeting is tentatively scheduled for Nov. 14, 2019, according to Amarin's press release. The FDA is therefore expected to extend Vascepa's regulatory timeline beyond the original Sept. 28 PDUFA date. That's not the end of the world, so long as the FDA does eventually green light Vascepa's new label.
Why is the FDA holding an advisory committee meeting? While the company didn't release any details at this early juncture, the most likely reason is the mineral oil placebo issue.
In Vascepa's large cardiovascular outcomes trial known as Reduce-It, patients in the placebo arm reportedly experienced a noteworthy increase in bad cholesterol levels, which may have exaggerated Vascepa's observed cardio-protective benefits to some degree. On the plus side, this non-inert placebo issue shouldn't turn out to be a showstopper, meaning that bargain hunters may want to take advantage of this sizable drop in Amarin's stock.
