Seeks Addition of STEMI Indication for AGGRASTAT
WINNIPEG, Canada I September 10, 2015 I Medicure Inc. (“Medicure” or the “Company“) (TSXV:MPH, OTC:MCUJF), a specialty pharmaceutical company, is pleased to announce that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the label for AGGRASTAT (tirofiban HCl) to include the treatment of patients presenting with ST segment elevation myocardial infarction (STEMI). AGGRASTAT is currently approved by the FDA for treatment of patients presenting with non-ST segment elevation acute coronary syndrome (NSTE ACS). If approved for STEMI, AGGRASTAT would be the first in its class of Glycoprotein IIb/IIIa Inhibitors (GPI) to receive such a label in the United States.
“We have received substantial feedback from physicians that there is a need for more potent antiplatelet therapy when treating STEMI patients undergoing percutaneous coronary intervention (PCI),” stated Dawson Reimer, President and Chief Operating Officer of Medicure Inc. “We believe the STEMI indication would increase the utility of AGGRASTAT for physicians, and thereby increase hospital adoption and demand. We look forward to hearing from the FDA on this sNDA submission.”
In previous communication with the Company, the FDA’s Division of Cardiovascular and Renal Drug Products indicated its willingness to review and evaluate this label change request based substantially on data from the On-TIME 2 studyi, with additional support from published studies and other data pertinent to the use of the AGGRASTAT high-dose bolus (HDB) regimen in the treatment of STEMI. The efficacy and safety of the HDB regimen in STEMI has been evaluated in more than 20 clinical studies involving over 11,000 patients and is currently recommended by the ACCF/AHA Guideline for the Management of STEMI.ii
In October 2013, the STEMI indication for AGGRASTAT HDB was approved in Europe, based substantially on the same clinical data submitted in the Company’s sNDA. AGGRASTAT is the most used GPI in Europe and globally. Also in October 2013, the U.S. FDA approved AGGRASTAT’s HDB regimen pursuant to a previous sNDA submission by the Company. Since that time, sales of AGGRASTAT in the United States have increased by over 400%.
The Company anticipates that the filing of the sNDA will result in a Prescription Drug User Fee Act (PDUFA) action date for the STEMI sNDA in July 2016. Under PDUFA, the FDA aims to complete its review within ten months from the receipt of a sNDA submission. The sNDA filing is accompanied by a mandatory US $1.167 million user fee paid by Medicure International, Inc. to the FDA.
The Company’s subsidiary, Medicure International, Inc. (Barbados) holds the rights to AGGRASTAT in the United States and its territories.
About On-TIME 2
The On-TIME 2 trial was a multi-center, prospective, randomized, controlled clinical trial which was designed to assess the effect of AGGRASTAT using the HDB regimen (25 mcg/kg followed by a 0.15 mcg/kg/min maintenance infusion) in patients with STEMI planned for primary PCI. All patients received ASA, a 600 mg loading dose of clopidogrel, and unfractionated heparin. The study was accomplished in two phases: a pilot, open label phase (n=414) followed by a larger double-blind phase (n=984). A pooled analysis of data from both phases was pre-specified to evaluate the effect of the AGGRASTAT HDB regimen compared to control as measured by a primary endpoint defined as the 30-day MACE rate (death, recurrent MI and uTVR). In this pooled analysis, MACE at 30 days was significantly reduced by initiation of AGGRASTAT compared to control (5.8% vs. 8.6%; p=0.043). The clinical benefit seen in the primary PCI population at 30 days was sustained at one year, as results indicated a significantly lower total mortality (2.4% vs. 5.5%, p=0.007) and cardiac mortality rate (1.4% vs. 4.3%, p=0.003) associated with AGGRASTAT versus the control arm. In patients receiving a stent, the incidence of early (0–30 days) stent thrombosis was 2.1 vs. 5.2% (p =0.006) in the AGGRASTAT and control group, respectively, which was driven by a reduction in the incidence of acute (0–24 h) stent thrombosis between the two treatment groups (0.2% vs. 3.0%; p < 0.001). The incidence of 30-day mortality was significantly reduced in patients receiving AGGRASTAT compared to control (1.0% vs. 3.1%; p = 0.02, respectively) among patients undergoing primary PCI and receiving a stent.
About Medicure Inc.
Medicure is a specialty pharmaceutical company focused on the development and commercialization of therapeutics for the U.S. hospital market. The primary focus of the Company and its subsidiaries is the marketing and distribution of AGGRASTAT (tirofiban HCl) for non-ST elevation acute coronary syndrome in the United States, where it is sold through the Company’s U.S. subsidiary, Medicure Pharma, Inc. For more information on Medicure please visit www.medicure.com.
About AGGRASTAT
Indications and Usage
AGGRASTAT is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).
Dosage and Administration
Administer intravenously 25 mcg/kg within 5 minutes and then 0.15 mcg/kg/min for up to 18 hours. In patients with creatinine clearance ≤60 mL/min, give 25 mcg/kg within 5 minutes and then 0.075 mcg/kg/min.
Clinical Experience
In clinical studies with the HDB regimen, AGGRASTAT was administered in combination with aspirin, clopidogrel and heparin or bivalirudin to over 8,000 patients for typically ≤24 hours.
Contraindications
Known hypersensitivity to any component of AGGRASTAT, history of thrombocytopenia with prior exposure to AGGRASTAT, active internal bleeding, or history of bleeding diathesis, major surgical procedure or severe physical trauma within previous month.
Warnings and Precautions
Aggrastat can cause serious bleeding. If bleeding cannot be controlled discontinue AGGRASTAT. Thrombocytopenia: Discontinue AGGRASTAT and heparin.
Adverse Reactions
Bleeding is the most commonly reported adverse reaction.
For more information on AGGRASTAT, please refer to Full Prescribing Information.
i ten Berg JM et al. Effect of early, pre-hospital initiation of high bolus dose tirofiban in patients with ST-segment elevation myocardial infarction on short- and long-term clinical outcome. J Am Coll Cardiol 2010;55:2446-2455
ii O’Gara PT et al. 2013 ACCF/AHA Guideline for the management of ST-elevation myocardial infarction. J Am Coll Cardiol 2013;61:485-510
SOURCE: Medicure
Post Views: 22
Seeks Addition of STEMI Indication for AGGRASTAT
WINNIPEG, Canada I September 10, 2015 I Medicure Inc. (“Medicure” or the “Company“) (TSXV:MPH, OTC:MCUJF), a specialty pharmaceutical company, is pleased to announce that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the label for AGGRASTAT (tirofiban HCl) to include the treatment of patients presenting with ST segment elevation myocardial infarction (STEMI). AGGRASTAT is currently approved by the FDA for treatment of patients presenting with non-ST segment elevation acute coronary syndrome (NSTE ACS). If approved for STEMI, AGGRASTAT would be the first in its class of Glycoprotein IIb/IIIa Inhibitors (GPI) to receive such a label in the United States.
“We have received substantial feedback from physicians that there is a need for more potent antiplatelet therapy when treating STEMI patients undergoing percutaneous coronary intervention (PCI),” stated Dawson Reimer, President and Chief Operating Officer of Medicure Inc. “We believe the STEMI indication would increase the utility of AGGRASTAT for physicians, and thereby increase hospital adoption and demand. We look forward to hearing from the FDA on this sNDA submission.”
In previous communication with the Company, the FDA’s Division of Cardiovascular and Renal Drug Products indicated its willingness to review and evaluate this label change request based substantially on data from the On-TIME 2 studyi, with additional support from published studies and other data pertinent to the use of the AGGRASTAT high-dose bolus (HDB) regimen in the treatment of STEMI. The efficacy and safety of the HDB regimen in STEMI has been evaluated in more than 20 clinical studies involving over 11,000 patients and is currently recommended by the ACCF/AHA Guideline for the Management of STEMI.ii
In October 2013, the STEMI indication for AGGRASTAT HDB was approved in Europe, based substantially on the same clinical data submitted in the Company’s sNDA. AGGRASTAT is the most used GPI in Europe and globally. Also in October 2013, the U.S. FDA approved AGGRASTAT’s HDB regimen pursuant to a previous sNDA submission by the Company. Since that time, sales of AGGRASTAT in the United States have increased by over 400%.
The Company anticipates that the filing of the sNDA will result in a Prescription Drug User Fee Act (PDUFA) action date for the STEMI sNDA in July 2016. Under PDUFA, the FDA aims to complete its review within ten months from the receipt of a sNDA submission. The sNDA filing is accompanied by a mandatory US $1.167 million user fee paid by Medicure International, Inc. to the FDA.
The Company’s subsidiary, Medicure International, Inc. (Barbados) holds the rights to AGGRASTAT in the United States and its territories.
About On-TIME 2
The On-TIME 2 trial was a multi-center, prospective, randomized, controlled clinical trial which was designed to assess the effect of AGGRASTAT using the HDB regimen (25 mcg/kg followed by a 0.15 mcg/kg/min maintenance infusion) in patients with STEMI planned for primary PCI. All patients received ASA, a 600 mg loading dose of clopidogrel, and unfractionated heparin. The study was accomplished in two phases: a pilot, open label phase (n=414) followed by a larger double-blind phase (n=984). A pooled analysis of data from both phases was pre-specified to evaluate the effect of the AGGRASTAT HDB regimen compared to control as measured by a primary endpoint defined as the 30-day MACE rate (death, recurrent MI and uTVR). In this pooled analysis, MACE at 30 days was significantly reduced by initiation of AGGRASTAT compared to control (5.8% vs. 8.6%; p=0.043). The clinical benefit seen in the primary PCI population at 30 days was sustained at one year, as results indicated a significantly lower total mortality (2.4% vs. 5.5%, p=0.007) and cardiac mortality rate (1.4% vs. 4.3%, p=0.003) associated with AGGRASTAT versus the control arm. In patients receiving a stent, the incidence of early (0–30 days) stent thrombosis was 2.1 vs. 5.2% (p =0.006) in the AGGRASTAT and control group, respectively, which was driven by a reduction in the incidence of acute (0–24 h) stent thrombosis between the two treatment groups (0.2% vs. 3.0%; p < 0.001). The incidence of 30-day mortality was significantly reduced in patients receiving AGGRASTAT compared to control (1.0% vs. 3.1%; p = 0.02, respectively) among patients undergoing primary PCI and receiving a stent.
About Medicure Inc.
Medicure is a specialty pharmaceutical company focused on the development and commercialization of therapeutics for the U.S. hospital market. The primary focus of the Company and its subsidiaries is the marketing and distribution of AGGRASTAT (tirofiban HCl) for non-ST elevation acute coronary syndrome in the United States, where it is sold through the Company’s U.S. subsidiary, Medicure Pharma, Inc. For more information on Medicure please visit www.medicure.com.
About AGGRASTAT
Indications and Usage
AGGRASTAT is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).
Dosage and Administration
Administer intravenously 25 mcg/kg within 5 minutes and then 0.15 mcg/kg/min for up to 18 hours. In patients with creatinine clearance ≤60 mL/min, give 25 mcg/kg within 5 minutes and then 0.075 mcg/kg/min.
Clinical Experience
In clinical studies with the HDB regimen, AGGRASTAT was administered in combination with aspirin, clopidogrel and heparin or bivalirudin to over 8,000 patients for typically ≤24 hours.
Contraindications
Known hypersensitivity to any component of AGGRASTAT, history of thrombocytopenia with prior exposure to AGGRASTAT, active internal bleeding, or history of bleeding diathesis, major surgical procedure or severe physical trauma within previous month.
Warnings and Precautions
Aggrastat can cause serious bleeding. If bleeding cannot be controlled discontinue AGGRASTAT. Thrombocytopenia: Discontinue AGGRASTAT and heparin.
Adverse Reactions
Bleeding is the most commonly reported adverse reaction.
For more information on AGGRASTAT, please refer to Full Prescribing Information.
i ten Berg JM et al. Effect of early, pre-hospital initiation of high bolus dose tirofiban in patients with ST-segment elevation myocardial infarction on short- and long-term clinical outcome. J Am Coll Cardiol 2010;55:2446-2455
ii O’Gara PT et al. 2013 ACCF/AHA Guideline for the management of ST-elevation myocardial infarction. J Am Coll Cardiol 2013;61:485-510
SOURCE: Medicure
Post Views: 22
