Amarin’s hope of an expanded indication for its triglyceride medication Vacepa got an additional dent on Tuesday. The company noted in an SEC filing that the FDA will no longer accept data from its ANCHOR study as support for its sNDA to expand the indication to include patients with elevated triglycerides. The drug is currently approved for patients with hypertriglyceridemia.
Forbes notes that that the special protocol study known as ANCHOR was designed according to a special agreement with the FDA and that Amarin thought the study could lead to an expanded indication while it also waited for data from a second trial—known as REDUCE-IT—to roll its way, even though the trial is not expected to end until 2016. Forbes notes that these special agreements are not contracts and the FDA has the latitude to tell the drugmaker the trial is insufficient.
Amarin wrote in its 8K that the FDA said data from other trials—ACCORD, AIM-HIGH and HPS2-THRIVE—fail to show the drug significantly reduces cardiovascular risk among patients with triglyceride levels below 500mg/dL.
An FDA advisory panel voted 9-2 against the expanded indication earlier this month, prompting Jefferies analyst Thomas Wei to write at the time that the drug’s value would be around $1 per share if it failed to get the added indication.
The December 20 PDUFA date still stands.
