Amarin Corporation AMRN traded higher after the FDA's Endocrinologic and Metabolic Drug Advisory Committee voted 16-0 to recommend approval of label expansion for Vascepa capsules to include reduction in the risk of cardiovascular, or CV, events in high-risk patients. Vascepa is the company's fish oil pill.
Vascepa was initially approved in 2012 as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.
The Adcom reviewed the drug based on the results from the Phase 3 REDUCE-IT CV outcomes trial, which showed that the addition of Vascepa to statin therapy brought down the risk of cardiovascular events by 25% compared to statins along with mineral oil, which was used as placebo.
"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," said Amarin CEO John Thero.
Labeling Discussions In Focus
There were few surprises brought up during the meeting, Cantor Fitzgerald analyst Louise Chen said in a note. Vascepa appears well on track for approval by year end. The committee members agreed the REDUCE-IT data are meaningful enough to warrant approval.
The target population for CV events is much bigger than the triglyceride reduction indication for which Vascepa was approved initially, according to Fierce Pharma.
The FDA still has more wrinkles to iron out, as relayed by two significant discussions among committee members about the labeling.
The committee discussed whether the approval is warranted in both primary prevention and secondary prevention patients, or just the secondary prevention cohort. FDA staffers have also had discussions about the appropriate minimum triglyceride level.
"Given differing opinions across the panel, we think it is difficult to see a clear/definitive read-through to what the FDA may ultimately decide on for the approved label and believe this will continue to be an important focus as we approach the approval decision," Chen wrote in a note.
With the peak sales potential of Vascepa underappreciated, Chen said upward earnings revisions not reflected in the consensus expectations should drive Amarin shares higher.
Amarin said it expects to have labeling discussions with the FDA, as it prepares for Vascepa launch for the expanded indication on or before the PDUFA goal date of Dec. 28.
Meanwhile, Vascepa prescriptions has grown meaningfully since pre-REDUCE-IT leberls, Chen said. The focus now shifts to the Vascepa IP debate, although the company is expected to prevail in it.
Cantor has an Overweight rating and $35 price target on Amarin. The stock traded higher by 13.% to $24.33 per share at time of publication.
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