Amarin Files Supplemental NDA With FDA for Vascepa Based on REDUCE-IT Results

Results from the landmark REDUCE-IT cardiovascular (CV) outcomes study, regarding Amarin’s drug Vascepa (icosapent ethyl), have prompted action from both the pharmaceutical company and the American Diabetes Association (ADA).^1,2 Amarin has submitted a supplemental new drug application (sNDA) to the FDA as it looks to expand label indication for Vascepa, according to a press release issued by the drugmaker, and the ADA has included the drug in a mid-year update to the 2019 Standards of Medical Care in Diabetes (Standards of Care), including a recommendation to add icosapent ethyl to statin therapy for patients with high triglyceride levels to reduce the risk of CV events in patients with diabetes, according to a statement from the ADA.

Amarin submitted the sNDA to federal regulators March 28, 2019, a little more than a week after researchers presented a new round of results from REDUCE-IT at the American College of Cardiology (ACC) in New Orleans. Results presented at ACC show that icosapent ethyl, derived from omega-3 fatty acid, a component of fish oil reduced the risk of first and subsequent CV events by 30%. These results followed the inital presentation of REDUCE-IT at the American Heart Association in November 2018, which showed the drug reduced initial CV events by 25%. The sNDA included results from more than 35,000 patients, according to the company's statement.^1,3

The FDA has received Amarin’s sNDA submission for an expanded indication for icosapent ethyl but has not yet issued a timeframe for a review. An FDA review of an sNDA request usually begins 60 to 74 days after the agency acknowledges its submission. Amarin said in its statement that it expects FDA to schedule an advisory committee meeting but does not know when it will be. If FDA follows the normal 10-month review period, a Prescription Drug User Fee Act (PDUFA) date would fall near the end of January 2020.

"This submission is another step forward toward our goal to help address the risk of cardiovascular disease. The REDUCE-IT results support that approximately 1 fewer major cardiovascular adverse event would occur on average for every 6 patients treated with Vascepa for 5 years on top of statin therapy compared to placebo1. This unprecedented result beyond cholesterol management presents an important new preventative care opportunity for millions of patients," John F. Thero, president and chief executive officer of Amarin, said in the company's statement.

ADA Updates Standards of Care

On March 27, 2019, ADA included an update for icosapent ethyl in an update to Standards of Care based on results from REDUCE-IT.² Of the study participants, 59% had diabetes at baseline. The update regarding the drug adds a Level “A” recommendation to consider icosapent ethyl as a treatment to lower the risk of CV in patients with diabetes, atherosclerotic cardiovascular disease (ASCVD), elevated triglycerides, and other cardiac risk factors. ASCVD is the leading cause of death among individuals with diabetes.

Craig B. Granowitz, MD, PhD, senior vice president and chief medical officer of Amarin said in a statement, “While we know that the benefits of Vascepa are not limited to people with diabetes, we are very pleased by ADA’s recognition of the importance of the REDUCE-IT study and its unprecedented outcomes by including Vascepa in the ADA Standards of Care.”

Updates to the Standards of Care are proposed and reviewed by the ADA’s Professional Practice Committee.

In patients with ASCVD or other cardiac risk factors on a statin with controlled LDL-C, but elevated triglycerides (135-499), the addition of icosapent ethyl should be considered to reduce CV risk.

Reference

1. Amarin submits supplemental new drug application (sNDA) to US FDA seeking new indication for Vascepa® (icosapent ethyl) to reduce the risk of major adverse cardiovascular events based on landmark REDUCE-IT™ cardiovascular outcomes study. Amarin Corporation; March 28, 2019. https://investor.amarincorp.com/news-releases/news-release-details/amarin-submits-supplemental-new-drug-application-snda-us-fda. Accessed April 1, 2019.

2. American Diabetes Association® issues critical updates to the 2019 Standards of Medical Care in Diabetes. Arlington, VA: American Diabetes Association; March 27, 2019. http://www.diabetes.org/newsroom/press-releases/2019/ada-issues-critical-updates-to-2019-standards-of-care.html. Accessed April 1, 2019.

3. Vascepa® (icosapent ethyl) showed 30% reduction in total cardiovascular events including recurrent events in REDUCE-IT™. Presented at: The American College of Cardiology’s 68th Annual Scientific Session; March 16-18, 2019; New Orleans. LA. https://www.multivu.com/players/English/8512651-amarin-reduce-it-vascepa-30-percent-reduction-total-cardiovascular-events/. Accessed April 1, 2019.