Vascepa Granted FDA Priority Review


Amarin announced the FDA had granted their sNDA for icosapent ethyl to reduce residual CV risk in patients with statin-managed LDL-C cholesterol.

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Officials from Amarin have announced that the US Food and Drug Administration has granted priority review for icosapent ethyl (Vascepa) Supplemental New Drug Application.

Icosapent ethyl, which is produced by Amarin, is a fish-oil based drug that had previously received FDA approval for the reduction of triglyceride levels in adult patients with severe hypertriglyceridemia. With a PDUFA date in Sept. 2019, which is 4 months earlier than expected, icosapent ethyl could become the first drug indicated to reduce residual cardiovascular risk in patients with statin-managed LDL-C cholesterol, but persistent elevated triglycerides.

“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,” said John Thero, president and CEO of Amarin. “Our plans to significantly expand promotion of Vascepa following label expansion are being accelerated to reflect the upcoming PDUFA date."

Amarin submitted the results of the REDUCE-IT trial, which examined the use of 4mg icosapent ethyl in reducing total cardiovascular events, to the FDA in March. The trial involved more than 8,000 patients and found that icosapent ethyl showed a 30% reduction in total cardiovascular events compared to placebo in the statin-treated population studies in REDUCE-IT.

Patients involved in the REDUCE-IT, which had a median follow-up time of 4.9 years, found that icosapent ethyl reduced total events by 30% compared to placebo. These results reflected that for every 1000 patients treated for 5 years, approximately 159 major adverse cardiovascular events could be prevented. Study authors also noted a 28% reduction of total events in the study’s key secondary endpoint of 3-point major adverse cardiovascular events in the intent-to-treat population.

"This is an impressive degree of risk reduction," said study author Deepak Bhatt, of Brigham and Women’s Hospital. "From a patient's perspective — and from my perspective as a physician — we care about repeat events and the risk of surviving a first stroke or heart attack only to go on to have a subsequent, and potentially fatal, event.”

In the first week of May, icosapent ethyl’s total prescriptions had jumped 67.1% over the previous year with new prescriptions growing by 76.5%. The PDUFA date for icosapent ethyl is Sept. 28, 2019.

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