OPDP joins Amarin's Vascepa tale
Amarin's fish-oil drug Vascepa continued to take a beating as 2013 wrapped. Among the lowish lights in the company's pursuit of an indication that would allow a broader patient population to use the triglyceride-lowering medication: a 9-2 advisory panel vote against an expanded indication, and the FDA's decision to reject results from the ANCHOR study to support the expanded indication. The FDA's ability to backtrack on ANCHOR was within its rights, and the purpose was that the study would provide an immediate data pool while Amarin waited for other trial data to roll in.
The FDA then upset the generally linear order of things—panel review, regulator decision—Dec. 20 saying it was not going to rule on the drug which had a Dec. 29 PDUFA date. MKM Partners managing director John LeCroy told Reuters that was “a positive relative to Amarin getting a rejection.”
Adding to the tension—which Reuters noted had sapped the company's stock—was yet another negative: an untitled Dec. 16 letter in which the regulator calls out the drug maker for focusing so much on the drug's efficacy claims on a webcast series invitation that the risks associated with the drug did not make it onto the page, an omission the FDA writes “misleadingly suggests that Vascepa is safer than has been demonstrated.”
The regulator also noted that a printed direction to “see full prescribing information” was a solution it would not buy into because the instructions fail to “mitigate the misleading omission of risk information from the print invitation.”