Business
HLS Therapeutics Files New Drug Submission for Vascepa® in Canada
HLS Therapeutics Files New Drug Submission for Vascepa® in Canada Canada News...
About this update from Hls Therapeutics, Inc.
[{"type":"text","content":"\n\n\n\nHLS Therapeutics Files New Drug Submission for Vascepa® in Canada\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, April 29, 2019\n\n\n\nCardiovascular disease is the leading cause of death globally1 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 Vascepa has been granted priority review status by Health Canada, which could reduce review time by up to four-and-a-half months TORONTO, April 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 it has filed a New Drug Submission (\"NDS\") with Health Canada for Vascepa®. Within the NDS, Vascepa (icosapent ethyl) is proposed to be indicated to reduce the risk of Major Adverse Cardiovascular Events (\"MACE\") in statin-treated patients with elevated triglycerides and other risk factors. \n\"We are pleased to reach this milestone with Vascepa and look forward to working with Health Canada to bring this innovative therapy to Canadians who may be at-risk of a major cardiac event,\" said Greg Gubitz, CEO of HLS. \"With cardiovascular disease as the leading cause of death worldwide, we believe that Vascepa has the potential to be a platform from which we can enhance the quality of life for many Canadians and grow our cardiovascular business for years to come.\"\nVascepa has been granted priority review status by Health Canada which 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.\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 MACE. REDU...