FDA fast-tracks new CV indication for Vascepa

The U.S. FDA on May 29 granted Amarin’s Vascepa (icosapent ethyl) priority review for a supplemental indication that would state the medication reduces cardiovascular risk in addition to helping patients manage elevated triglyceride levels.

While Vascepa is already approved to treat severe hypertriglyceridemia in adults—and has been for seven years—the new indication would expand its benefits to cardiovascular risk reduction in patients with statin-managed LDL-cholesterol but persistent elevated triglycerides. According to a statement from Amarin, if the FDA approves Vascepa’s additional indication it will be the first drug indicated to reduce residual CV risk in these patients.

The latest indication is reflective of the REDUCE-IT trial, in which more than 8,000 statin-treated adults with high cardiovascular risk saw 25% and 20% reductions in major adverse cardiovascular events and fatalities, respectively, with Vascepa. With priority review, the FDA will review the drug within six months instead of 10, and Amarin can expect a decision by Sept. 28 of this year.

“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,” president and CEO of Amarin John F. Thero said in a statement. “These patients will be the focus of our planned expanded REDUCE-IT promotional efforts.”

CNBC reported Amarin shares had surged 15% by Wednesday afternoon, just hours after the FDA announced it would fast-track its review of Vascepa. The company’s stock has reportedly risen more than 56% since last September, when REDUCE-IT results were first released to the public, and PM Live reported Amarin’s sales could top $1 billion per year if the FDA goes through with this approval.