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FDA accepts filing of new drug application for prescription icosapent ethyl
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Amarin Corp. announced that the supplemental new drug application for icosapent ethyl has been accepted for filing by the FDA and has been granted priority review designation.
If approved, icosapent ethyl (Vascepa) will be the first drug to reduce residual CV risk in patients whose LDL is managed with statin therapy but who continue to have elevated triglycerides, according to a press release from Amarin.
“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,” John F. Thero, president and CEO for Amarin, said in the release.
The supplemental NDA is based on results from the REDUCE-IT trial. As Cardiology Today previously reported, icosapent ethyl was superior to placebo for reducing risk for ischemic events in patients with elevated triglycerides at high CV risk despite statin therapy. Another analysis presented in March found that icosapent ethyl demonstrated a 30% reduction in total ischemic events, including first and subsequent events.
“We believe the unprecedented REDUCE-IT results position Amarin to lead a transformative change in clinical practice for preventative treatment of cardiovascular disease, the leading cause of death for both men and women in the United States,” Thero said in the release.
The Prescription Drug User Fee Act goal date for the supplemental NDA for icosapent ethyl is Sept. 28, which is 4 months sooner than the standard review period due to its priority review designation, according to the release. The FDA has not specified whether an advisory committee meeting will be held to discuss this application, although Amarin has previously mentioned that a meeting is likely.
Disclosure: Thero is an employee of Amarin.
Editor’s Note: This article was updated on May 29, 2019 to change the headline at the request of Amarin.