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HLS Therapeutics Granted Priority Review Status from Health Canada for Vascepa®
HLS Therapeutics Granted Priority Review Status from Health Canada for Vascepa® ...
About this update from Hls Therapeutics, Inc.
[{"type":"text","content":"\n\n\n\nHLS Therapeutics Granted Priority Review Status from Health Canada for Vascepa®\n\n/* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n\n\n\n\n\n\n\nCanada NewsWire\nTORONTO, March 29, 2019\n\n\n\nCardiovascular disease is the leading cause of death globally1 HLS New Drug Submission (NDS) for Vascepa is supported by data from the REDUCE-IT™ trial, an international, multi-center cardiovascular outcomes study that showed a 25% placebo-controlled risk reduction in the first occurrence of major adverse cardiovascular events (MACE) HLS NDS filing to occur in April 2019 Priority review status can reduce review time by more than four-and-a-half months TORONTO, March 29, 2019 /CNW/ - HLS Therapeutics Inc. (\"HLS\" or the \"Company\") (TSX:HLS), a specialty pharmaceutical company focused on central nervous system and cardiovascular markets, announces that Health Canada has granted priority review status for its New Drug Submission (\"NDS\") for Vascepa®, which seeks to reduce the risk of ischemic cardiovascular events in statin-treated patients with elevated triglycerides and other risk factors.\nPriority 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.\nIn the fall of 2018, results of the REDUCE-IT™ study were presented and published showing that Vascepa achieved the primary endpoint of the study demonstrating a statistically significant 25% placebo-controlled risk reduction in the first occurrence of major adverse cardiovascular events (\"MACE\"). REDUCE-IT results also revealed statistically significant relati...