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Priority review status may be granted to regulatory filings in Canada for new

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Pervius
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Priority review status may be granted to regulatory filings in Canada for new treatments that potentially address serious, life-threatening conditions for which no drug is currently marketed in Canada, and for which there is substantial evidence of clinical effectiveness of that new treatment. Under priority review the performance target for the screening and review of the original submission is 215 calendar days versus 355 days for a standard review. Therefore, receipt of priority review status could expedite the launch of Vascepa in the Canadian market, if the product is ultimately approved by Health Canada.

While the NDS includes results from the REDUCE-IT™ cardiovascular outcomes study of Vascepa, review of this regulatory submission in Canada is anticipated to be independent of the review of the supplemental new drug application which Amarin recently filed with the U.S. Food and Drug Administration regarding Vascepa based on the same clinical study results.

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