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Medicure Receives Response Letter from FDA on AGGRASTAT® sNDA for New Indication
Medicure Receives Response Letter from FDA on AGGRASTAT® sNDA for New Indication ...
About this update from Medicure Inc.
[{"type":"text","content":"\n\n\n\nMedicure Receives Response Letter from FDA on AGGRASTAT® sNDA for New Indication\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.prntac{\nTEXT-ALIGN: CENTER\n}\n\n\n\n\n\n\nMedicure Receives Response Letter from FDA on AGGRASTAT® sNDA for New Indication\nCanada NewsWire\nWINNIPEG, July 7, 2016\n\n\n\nFDA Does Not Approve Application in its Present Form \n\n\n\nWINNIPEG, July 7, 2016 /CNW/ - Medicure Inc. (\"Medicure\" or the \"Company\") (TSXV:MPH, OTC:MCUJF), a specialty pharmaceutical company, announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) requesting an expanded indication for patients presenting with ST segment elevation myocardial infarction (STEMI).  \n\nThe FDA issued a Complete Response Letter to communicate that its initial review of the application is complete; however, it cannot approve the application in its present form and requested additional information. The On-TIME 2 trial1 provided the majority of supporting information for the sNDA submission. Medicure will work directly with the FDA to address these comments.\n\nThe efficacy and safety of the AGGRASTAT high-dose bolus (HDB) regimen has been evaluated in more than 30 clinical studies involving over 15,000 patients and is currently recommended in the ACCF/AHA/SCAI Guidelines2-4.  The STEMI indication for AGGRASTAT HDB was approved in Europe based substantially on the same clinical data submitted in the Company's sNDA.  As of now, none of the marketed Glycoprotein IIb/IIIa Inhibitors (GPI) are approved for STEMI in the United States.  \n\n\"We are evaluating the FDA's response and will work closely with the Agency to address their comments,\" stated Dr. Albert Friesen, Chief Executive Officer and President of Medicure Inc. \"In the meantime, AGGRASTAT continues to be the fastest growing GPI in the United States.\"  \n\nAbout On-TIME 2\n\nThe On-TIME 2 trial was a multi-center, prospective, randomized, controlled clinical trial which was designed to assess t...