Amarin has been on a scorching run with its fish-oil derivative Vascepa after a major cardiovascular outcomes trial last year set a possible blockbuster trajectory for the drug. Now, the FDA has voted to give Vascepa a major label boost with the addition of CV risk reduction––and those blockbuster sales could be on the near horizon.
The FDA approved Vascepa as an add-on to statins to reduce the risk of cardiovascular events in patients with elevated triglycerides who have either established CV disease or diabetes with two additional CV risk factors, the administration said Friday.
The indication settles a lingering question around Vascepa's expanded label of whether the FDA would limit the drug's patient pool to only those with a preexisting CV disease or expand it to the much larger population of patients at high risk of disease.
With a broader label in hand, Vascepa is now poised to become the blockbuster drug Amarin hoped it would become after a major outcomes trial last year showed the drug on top of statins cut the risk of CV events by 25% in patients with abnormally high triglyceride levels.
Amarin raised its 2020 sales forecast to between $600 million and $700 million as it plans to roll out an expanded sales team of 800 by mid-January, CEO John Thero said Friday. With the new label, Thero said Amarin was expecting peak sales estimates in the "multiple billions."
"We are creating a market here and going where people have not gone before," he said. "Our focus is on improving patient care and executing on our plan."
Vascepa has now been approved for a possible patient population that runs into the tens of millions, Thero said.
"This is an indication that gives physicians tools to treat their high-risk patients, whether those are patients with an established CV disease or diabetes with other CV risk factors," he said. "This is a lot of patients."
The FDA's approval follows an advisory committee's unanimous vote in November to recommend the drug's expanded label. In that review, committee members were tasked with investigating concerns that the control arm of Vascepa's outcomes trial, dubbed Reduce-It, may have had a skewing effect on the drug's results.
The trial tested Vascepa as an add-on to statin therapy, compared with the mineral oil placebo paired with statins. The FDA examined whether that mineral oil interfered with patients' ability to absorb statin therapy and artificially raised patients' cholesterol levels, but it called the study "inconclusive," John Sharretts, acting deputy director of the FDA's division of metabolism and endocrinology products, said in a briefing at the time.
With Vascepa now a likely blockbuster candidate, already sky-high speculation about Amarin's acquisition by a major player will likely continue apace.