The US Food and Drug Administration (FDA) has awarded priority review designation to Amarin’s supplemental new drug application (sNDA) for Vascepa (icosapent ethyl) in cardiovascular (CV) risk reduction.
A Prescription Drug User Fee Act (PDUFA) date has been set to 28 September 2019, which is four months earlier than anticipated.
Amarin is seeking approval for the use of Vascepa to decrease residual CV risk in patients with statin-managed low-density lipoprotein cholesterol (LDL-C) but persistently elevated triglycerides (TG).
The drug is currently indicated as an adjunct to diet to reduce TG levels in adults with severe hypertriglyceridemia.
Amarin president and CEO John Thero said: “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.
“Our plans to significantly expand promotion of Vascepa following label expansion are being accelerated to reflect the upcoming PDUFA date.”
The company’s sNDA for Vascepa includes results from the REDUCE-IT cardiovascular outcomes study, which was conducted in 8,179 statin-treated adults with increased CV risk.
REDUCE-IT met its primary endpoint, demonstrating a 25% relative risk reduction in the first occurrence of a major adverse CV event (MACE) compared to placebo in the intent-to-treat population.
MACE was assessed as a composite of CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation and unstable angina requiring hospitalisation.
Vascepa met the study’s key secondary endpoint with a 26% relative risk reduction in three-point MACE, a composite of CV death, non-fatal heart attack and non-fatal stroke.
The drug further achieved seven additional secondary endpoints, including a 20% relative risk reduction in cardiovascular death, compared to placebo. It is not uncommon for clarification on this topic to be provided by the FDA later in its review process.
