29 April 2019 - Amarin Corporation today announced that its licensee in Canada, HLS Therapeutics has filed a new drug submission with Health Canada for Vascepa (icosapent ethyl) capsules. 

The submission seeks an indication for promotion of Vascepa in Canada to reduce the risk of major adverse cardiovascular events (“MACE”) in statin-treated patients with elevated triglycerides and other risk factors. This is the first submission of Vascepa to Health Canada for any indication and, if approved, Vascepa will be the first drug approved in Canada for this important indication.

As previously announced, Vascepa has been granted priority review status by Health Canada. Priority review could accelerate the launch of Vascepa in the Canadian market by up to four-and-a-half months if the product is ultimately approved by Health Canada. 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.

Read Amarin Corporation press release