FDA Decision on Icosapent sNDA Delayed for Advisory Committee Meeting

August 08, 2019
FDAThe US Food and Drug Administration (FDA) will be delaying decision on the supplementary New Drug Application (sNDA) for icosapent ethyl (Vascepa) to hold an advisory committee meeting on the investigative fish oil-based therapy.

The committee meeting, tentatively scheduled for November 14, will have to precede the sNDA PDUFA action date, previously set as September 28. The Amarin Corporation drug is seeking a supplemental indication for the reduction of residual cardiovascular risks in patients with elevated triglycerides. According to a notice sent from the FDA to Amarin, November 14 is the earliest date by which an advisory committee meeting could be scheduled.

Though Amarin has not yet received a PDUFA date extension, the company stated they anticipate an extension aligned with the FDA’s three-month standard. A new date in late December of this year would therefore offset 3 of the 4 months benefitting the sNDA from the FDA’s previous Priority Review designation.

The committee meeting’s intent is to review the sNDA for expansion of icosapent’s labeling, which is based on findings reported in the REDUCE-IT cardiovascular outcomes study.

The 8179-patient trial results, presented at the American Heart Association (AHA) 2018 Scientific Sessions, assessed the therapy versus placebo in patients with baseline fasting triglyceride levels of 135-499 mg per deciliter and a low-density lipoprotein cholesterol (LDL-C) level of 41-100 mg per deciliter. Investigators assessed for a primary endpoint of a composite of cardiovascular death, nonfatal myocardial infarction (MI), nonfatal stroke, coronary revascularization, or unstable angina.

The team also assessed for a key secondary endpoint of composite cardiovascular death, nonfatal MI, or nonfatal stroke.

Primary endpoint event occurred in significantly fewer treated patients (17.2%) than placebo patients (22.0%; HR .75; 95% CI: .65 - .83; P< .001), and the key secondary endpoint was also reached in fewer treated patients (11.2%) than placebo patients (14.8%; HR .74; 95% CI: .65 - .83; P< .001).

In a reassessment of the trial at the American Diabetes Association (ADA) 2019 Scientific Sessions this June, Robert S. Busch, MD, director of Clinical Research at Albany Medical College, called the findings a practice-changing event.

“It’s an obligation and a new standard of care from the ADA to know the triglyceride level in at-risk patients,” Busch said. “And if it’s raised, it’s also now an obligation to prescribe icosapent.”

Michael Miller, MD, REDUCE-IT investigator and director for the Center for Preventive Cardiology at the University of Maryland Medical Center, told MD Magazine® at AHA 2018 the future cardiovascular event risk reduction findings were unprecedented in the field.

“In this space—in the statin era—this is the first study to show a benefit on cardiovascular death on top of the 25% reduction in MACE events,” he said.



Amarin was informed by the FDA that an agenda for the meeting is currently being drafted. The company anticipates discussion pertaining to REDUCE-IT findings will be broad, and topics regarding the therapy to be consistent with those discussed in the initial publication of trial findings—including study conduct review, the observed patient populations, and the therapy’s efficacy and safety.

 John Thero, president and chief executive officer of Amarin, said in a statement the company looks forward to the advisory committee meeting as an opportunity to highlight REDUCE-IT data and the potential role of icosapent in reducing cardiovascular disease risk.

“We plan to continue to work collaboratively with the FDA on the pending REDUCE-IT sNDA while we prepare for a robust launch of REDUCE-IT data assuming approval of Vascepa before the end of 2019 for a cardiovascular risk reduction indication based on REDUCE-IT,” he said.
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