Following a priority review of Amarin’s fish oil-derived product Vascepa, an FDA advisory committee has unanimously voted to recommend its approval.
The Endocrinologic and Metabolic Drugs Advisory Committee of the FDA voted 16-0 to recommend the expansion of Vascepa (icosapent ethyl) to reduce the risk of cardiovascular events, such as heart attacks and stroke, in high-risk patients. Although the FDA is not bound to the recommendations of the committee, it is likely that it will approve the drug based on this advice.
The committee’s recommendation was based on the results of the REDUCE-IT trial, which evaluated Vascepa in more than 8,000 statin-treated adults with elevated cardiovascular risk. It achieved a reduction of 25% in major adverse cardiovascular events and a 20% reduction in deaths.
Vascepa is already approved for the treatment of elevated triglycerides – a risk factor for developing heart disease – but if approved, which is likely, it will see its usage rise significantly as it becomes available for potentially millions of people.
Despite an approval being almost certain at this point, questions still remain as to what specific population will be included on the expanded label.
Regardless of if it is approved for lower-risk patients – those who have not had a CV event but are at risk of having one – or for secondary prevention in those who have already suffered a CV event, Vascepa has the potential to reach over $1.5bn in annual sales, according to Wall Street analysts.
“Vascepa is positioned to be the first approved treatment to reduce cardiovascular events in the group of at-risk patients studied in the landmark REDUCE-IT clinical trial. We appreciate both the opportunity to present these results and the committee’s strong vote of confidence,” said John Thero, president and chief executive officer of Amarin.
The final decision on the details of the expanded label lies with the FDA, but Amarin will be on the up regardless of the specifics – the company saw its shares climb up to 21% following the news of the committee’s recommendation.
These gains also lend more credit to the ongoing speculation that Pfizer, among other companies, is interested in a possible buyout of Amarin.
Amarin is looking to launch Vascepa in the CV indication before the end of the year, with CEO Thero adding that the company is preparing to launch Vascepa on the assumption of a “FDA approval of our supplemental new drug application on or before the target PDUFA date of 28 December”.