Amarin could be just a few months away from a lucrative cardiovascular outcomes claim on the label for its fish oil-derived product Vascepa, after the FDA agreed a priority review for the application.
Shares in the Ireland-domiciled company closed up almost 12% yesterday after the priority review was announced, setting up a possible approval of the additional indication for the drug in September, around four months earlier than expected.
Vascepa (icosapent ethyl) is already approved to treat elevated triglycerides, a risk factor for heart disease, but could see its usage rise markedly if it also gets the new cardiovascular risk reduction claim.
Sales topped $77m in the first quarter of this year, but could rise above $1bn per year if the FDA approves the new indication, according to analysts, with some including Jefferies suggesting a peak of $2bn may even be possible.
The new filing is based on the stellar results of the REDUCE-IT trial in more than 8,000 statin-treated adults with elevated cardiovascular risk, reported last year. It achieved a reduction of 25% in major adverse cardiovascular events (MACE) and a 20% reduction in deaths.
Other drugs including Amgen’s injectable PCSK9 inhibitor Repatha (evolocumab) have achieved a similar level of efficacy in testing but Vascepa’s oral dosing, relatively low cost and absence of side effects is expected to make it particularly attractive to healthcare systems.
The highly purified version of the omega-3 acid commonly known as EPA in ethyl-ester form was approved by the FDA in 2012, and an attempt to extend its use into combination therapy with statins was rejected by an FDA panel in 2013 on the grounds that it wanted to see the REDUCE-IT data first.
The big question now is whether Vascepa will come up against an advisory committee this time around, and the company has said it thinks this is likely because it will be the first drug in line for approval in the large patient population studied in REDUCE-IT.
John Thero
“We expect earlier approval of an expanded indication for Vascepa to lead to faster improvements in care for millions of patients with residual cardiovascular risk after statin therapy,” said Amarin’s chief executive John Thero.
“We believe the unprecedented REDUCE-IT results position Amarin to lead a transformative change in clinical practice for preventative treatment of cardiovascular disease, the leading cause of death for both men and women in the US,” he added.
The news has also reignited speculation of a possible buyout of Amarin, with Pfizer rumoured to be among the companies interested in snapping it up. That speculation has helped Amarin’s stock rise more than 50% since the outcomes data was first presented last September.
Amarin has also said it will press ahead with a European filing for the Vascepa indication before the end of the year, but isn’t clear yet on whether it will do so alone or in partnership with another company.