FDA advisors support expanded indication for icosapent ethyl

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously Nov. 14 to recommend an expanded indication for icosapent ethyl (Vascepa), a purified omega-3 product designed to help heart patients keep their lipid levels in check. 

Sixteen members of EMDAC voted in favor of an extension that would label Vascepa as a medication that can reduce the risk of cardiovascular events in high-risk patients who take statins but still struggle with their LDL-cholesterol. Icosapent ethyl was first approved by the FDA seven years ago as a treatment for severe hypertriglyceridemia, but drugmaker Amarin said an expanded indication could make it the first drug indicated to reduce residual CV risk in those patients.

About six months ago, the FDA granted Vascepa priority review for the supplemental indication, citing positive results from the global REDUCE-IT study. In REDUCE-IT, more than 8,000 statin-treated adults with a high CV risk saw 25% and 20% reductions in major adverse cardiovascular events and fatalities, respectively, over seven years with Vascepa. CNBC reported that Amarin shares surged 15% within hours of the FDA announcing its fast-track designation—just a slice of a larger 56% rise in shares since last September, when REDUCE-IT results were first released to the public.

The National Lipid Association also publicly supported an expanded indication for icosapent ethyl in September, calling REDUCE-IT “an important contribution to our understanding of the use of omega-3 fatty acids in ASCVD risk reduction.” There’s been a fair amount of debate surrounding the efficacy of fish oil products for CVD reduction in the past year, but Amarin’s trial was heralded as a major success in the field. 

“The REDUCE-IT results are quite remarkable and illustrate how icosapent ethyl could transform the treatment of cardiovascular disease in the United States and worldwide,” Deepak L. Bhatt, MD, MPH, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital Heart and Vascular Center, said in a release from Amarin. “From my perspective as not only a researcher but also a practicing physician, icosapent ethyl represents one of the most important developments in the prevention and treatment of cardiovascular disease since statins and, if FDA approved, will be a critical tool for physicians to use to help prevent cardiovascular events such as heart attack and stroke.”

Since an endorsement from the EMDAC is far from an FDA approval itself, Amarin said it would be working with the agency to complete a review of the Vascepa proposal within the next month. Amarin president and CEO John F. Thero said the company is continuing to prepare for the launch of Vascepa, assuming the FDA will approve its sNDA on or before a target PDUFA date of Dec. 28.

“Today we moved an important step closer to potentially helping millions of patients who are at risk for cardiovascular events despite being on standard-of-care statin therapy,” Thero said in the company’s statement. “We appreciate both the opportunity to present these results and the committee’s strong vote of confidence.

“Thousands of patients and professionals contributed to the REDUCE-IT results. We look forward to having their sacrifices and contributions reflected in an expanded indication for Vascepa that has the potential to benefit millions of patients.”