Amarin submits supplemental NDA for icosapent ethyl

Amarin Corp. announced that it has submitted a supplemental new drug application to the FDA to expand the indication of icosapent ethyl to include the reduction of major adverse CV events.

The supplemental NDA for an expanded indication for icosapent ethyl (Vascepa) was based on results from the REDUCE-IT trial, according to a press release from the company.

As Cardiology Today previously reported, icosapent ethyl was superior to placebo for reducing the risk for ischemic events in patients with elevated triglycerides at high CV risk despite statin therapy.

“The REDUCE-IT results support that approximately one fewer major cardiovascular adverse event would occur on average for every six patients treated with Vascepa for 5 years on top of statin therapy compared to placebo,” John F. Thero, president and CEO of Amarin, said in the press release. “This unprecedented result beyond cholesterol management presents an important new preventive care opportunity for millions of patients.”

The FDA has acknowledged receipt of the application, although it is still unknown when it intends to review it, according to the press release. Unless told otherwise, the timing of the FDA’s review of the application can occur within 60 to 74 days of receipt. The company anticipates that there will be an advisory committee meeting in conjunction with the FDA’s application review, although the decision on whether there will be a meeting will not be made until the application has been substantially reviewed, according to the press release.

“Amarin is operating under the assumption that the [supplemental] NDA will be reviewed on a standard review clock of 10 months, resulting in a PDUFA date near the end of January 2020,” according to the press release.

Disclosure: Thero is an employee of Amarin.