Amarin's Vascepa granted priority review status from Health Canada
Apr. 01, 2019 8:21 AM ETAmarin Corporation plc (AMRN)HLTRF, HLS:CABy: Mamta Mayani, SA News Editor19 Comments
- Health Canada grants priority review status for Amarin's (NASDAQ:AMRN) licensee, HLS Therapeutics' (OTCPK:HLTRF) New Drug Submission (“NDS”) for Vascepa (icosapent ethyl) capsules.
- HLS Therapeutics anticipates filing the NDS in April, seeking approval to market and sell Vascepa in Canada to reduce the risk of ischemic cardiovascular events in statin-treated patients with elevated triglycerides and other risk factors.
- Priority review shortens the review the review period to 215 calendar days versus 355 days for a standard review.
- AMRN shares are up 1% premarket.