- Amarin surprised investors Thursday with an announcement the Food and Drug Administration plans to hold an advisory panel review of the biotech's heart drug Vascepa, a decision that just a week ago the company had called "unlikely."
- As a result, Amarin now does not expect the FDA to rule on an expanded approval for Vascepa until December, three months later than the late September decision date anticipated under a priority review announced in May.
- Amarin is seeking to broaden Vascepa's indication to include claims of a heart benefit in a wider population. Results from a trial of more than 8,000 patients, so-called REDUCE-IT, first announced last fall, showed Vascepa reduced heart risk by 25% compared to placebo.
Amarin appeared to be speeding toward winning approval heart labeling for Vascepa (icosapent ethyl).
With no word from the FDA on an advisory committee meeting, company CEO John Thero told investors last week that regulatory review of its supplemental application was "progressing in an orderly and timely manner."
That process is now derailed by a late notice from the FDA of its intent to hold a panel review, tentatively scheduled for November 14. Since that's roughly two weeks after the target action date for the FDA to decide on expanding Vascepa's use, Amarin is assuming a standard three-month extension to late December.
If that plays out, Amarin will have gained no advantage from the FDA's granting of priority review to its application.
Shares in the company fell by nearly a quarter to below $14 a share in post-market trading Thursday.
Amarin expects experts convened by the FDA to discuss REDUCE-IT's results broadly, including the study's design as well as Vascepa's safety and efficacy. Data from the trial widely impressed, but some questions have lingered around the mineral oil placebo used as a comparator to Vascepa, a point that could come up in expert discussions.
While a September approval may no longer be in the cards, Amarin intends to continue hiring sales representatives in preparation for an FDA decision. The plan is to double its current salesforce to about 800 employees.
Even without an OK, prescriptions of Vascepa have increased steadily, growing by more than 80% over last year's numbers through mid July, data from Symphony Health show. It is currently prescribed to reduce levels of trigylcerides in patients with severe elevations, a smaller population than what the REDUCE-IT trial would correspond to.
That early uptake has solidified expectations on Wall Street of a multi-billion dollar sales opportunity for Vascepa, and led Amarin to up sales forecasts for the year.
A three-month delay does not jeopardize that market, analysts from Cantor Fitzgerald wrote in a note to clients Thursday. Still, the surprise announcement may give investors a reason to interpret bullish proclamations from Amarin more cautiously.