FDA advisory panel unanimously backs Amarin's Vascepa to include preventing CV events in some patients

An FDA advisory committee voted 16-0 on Thursday in favour of approving a label expansion for Amarin's Vascepa (icosapent ethyl) to decrease cardiovascular (CV) risk in certain patients based on results from the REDUCE-IT outcomes trial. "There are some uncertainties here and there with these data, but most of them relate to their primary prevention cohort," remarked panelist Susan Ellenberg, saying she would "tend to leave it to clinical judgment about who should get" the fish-oil-derived drug.

Amarin is seeking to expand the label for Vascepa, which was approved in 2012 for severe hypertriglyceridaemia, to include the prevention of CV events in high-risk patients.

"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 [submission] on or before the target...date of December 28," Amarin stated.

Earlier this week, an FDA staff report concluded that the mineral oil placebo used in the trial, which some had suggested might have skewed the data in Amarin's favour, likely did not influence the results. Agency reviewers also highlighted some safety concerns in the study, including higher rates of atrial fibrillation and flutter among Vascepa-treated patients versus placebo, as well as more bleeding events, such as gastrointestinal bleeding or contusions.

"The mineral oil issue weighed on me," commented panel member Erica Brittain, and "I'm not 100% convinced it's not an issue, but I am enough convinced that the effect was probably minimal." She noted that Vascepa was associated with "very strong (effectiveness)...across all subgroups." However, panelist James de Lemos suggested the drug "should be approved for secondary prevention only," with Amarin needing to study Vascepa against a placebo in lower risk patients who had not previously suffered a cardiac event such as a heart attack or stroke.

Jefferies analyst Michael Yee said discussions about the label's wording is "a good debate to have...but will not dramatically impact the stock either way or consensus numbers." Prior to the committee vote, he estimated that the potential US market for Vascepa could reach 5 million to 15 million patients, though even having only 1 million patients on the drug could still generate $2.5 billion. Meanwhile, analysts at SVB Leerink predicted that Vascepa could eventually hit peak sales of $4 billion a year depending on the drug's label.

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