Amarin nabs priority review for FDA application seeking expanded approval of Vascepa

Amarin reported Wednesday that the FDA granted priority review to a filing seeking expanded approval of Vascepa (icosapent ethyl), assigning the application a target review date of September 28. The company noted that if authorised, Vascepa will be the first drug indicated to reduce residual cardiovascular risk in patients with statin-managed LDL-cholesterol, but persistent elevated triglycerides.

Vascepa was initially approved by the FDA in 2012 to reduce triglyceride levels in adults with severe hypertriglyceridaemia. The agency later agreed that Amarin could promote the therapy for off-label uses, with the company reporting earlier this month that prescriptions for the drug increased in the first quarter of 2019 by between 55 percent and 58 percent year-over-year.

"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," remarked John Thero, CEO of Amarin. The executive said "these patients will be the focus of our planned…promotional efforts," adding "our plans to significantly expand promotion of Vascepa following label expansion are being accelerated to reflect the upcoming [target review] date."

The priority review designation was supported by data from the REDUCE-IT cardiovascular outcomes study, with results unveiled in March showing that Vascepa lowered the risk of total cardiovascular events by 30 percent versus placebo in statin-treated patients (for related analysis, see ViewPoints: New cut of REDUCE-IT reinforces Vascepa as a breakthrough).

Amarin noted Wednesday that the FDA did not indicate at this time whether it plans to hold an advisory committee meeting to discuss the application. The company previously suggested that such a meeting "is likely." For additional analysis, see Physician Views Results - Cardiologist confidence in Vascepa grows as Amarin readies regulatory filing.

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