Amarin's Vascepa buzzkill: FDA stalls label review with surprise panel meeting

Amarin Vascepa pill
Amarin's Vascepa will face and FDA advisory committee meeting for claims the fish-oil pill reduces cardiovascular risks by 25%. (Amarin)

Everything has gone according to plan for Amarin’s fish-oil pill Vascepa, with scripts booming and a fast-track review underway for a label update. Only one thing could put a damper on the drug’s rosy outlook: the FDA taking a closer look at its cardiovascular benefits.

And that's exactly what it plans to do. 

The FDA will hold an advisory committee meeting Nov. 14 to review Amarin’s application to include a reduced risk of cardiovascular events in patients with abnormally high triglyceride levels on Vascepa’s label.

The label decision was initially set for Sept. 28, but Amarin now says it could be delayed until late December.

In a release, Amarin said the committee would likely target the results of Vascepa’s Reduce-It outcomes trial, which showed a 26% risk reduction for cardiovascular events over placebo. Those trial results, unveiled in October, were touted as a “landmark” achievement for Vascepa and a potential sign of a blockbuster drug in the making.

RELATED: Amarin CEO: When it comes to Vascepa expansion, 'we can do this on our own'

On the heels of those promising results, sales of the drug rocketed to $100.4 million in the second quarter—a 91% increase over the same period in the previous year. Amarin was so confident in those sales that it made the surprising decision in July to raise $400 million in cash to fund a massive commercial expansion on Vascepa’s expected label update, including doubling its sales force and fleshing out of its inventory to meet increased demand.

In response to the FDA notice, Amarin said it would continue its sales hiring plan despite the delay to “better prepare” for the expected expanded launch.

RELATED: Amarin's $400M-plus offering put investors on edge. Is a buyout off the table?

While the FDA’s decision to take a second look at Vascepa’s results does mean a temporary setback in Amarin’s plans, that may not be a bad thing for the drug’s future, Jefferies analyst Michael Yee said.

While an advisory committee meeting was unexpected, Yee said, it’s not unusual given the gravity of Vascepa’s results and what they could mean for the future of the drug and the cardiovascular field on the whole.

“While some investors might be a bit upset/frustrated since they just raised money, we think this is a buying opportunity because it's not shocking to have a panel and this should get approved and go right back up,” Yee wrote in a note to investors. “Overall, we predict the FDA will approve the drug given clearly significant (and transformative) evidence of benefit for an unmet need.”

RELATED: Amarin’s Vascepa cuts heart risks in key trial, but placebo noise fuels controversy

One possible sticking point in the drug’s review is concern that issues with Reduce-It’s placebo arm skewed Vascepa’s trial results.

Critics of the study said the placebo pill may have increased negative CV biomarkers, including bad cholesterol levels, but Yee noted that Amarin launched a post hoc review that found little connection between the placebo results and Vascepa’s benefits.

If the FDA approves Vascepa’s label expansion, the drug could reach peak sales of between $2 billion and $3 billion, Yee said.