Medicure has submitted a supplemental New Drug Application (sNDA) to the US 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. If approved for STEMI, Aggrastat would be the first in its class of glycoprotein IIb/IIIa inhibitors to receive such a label in the USA.
“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. “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 study, with additional support from published studies and other data pertinent to the use of the Aggrastat high-dose bolus regimen in the treatment of STEMI. The efficacy and safety of the high-dose bolus 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.
In October 2013, the STEMI indication for Aggrastat high-dose bolus was approved in Europe, based substantially on the same clinical data submitted in the company’s sNDA. Aggrastat is the most used glycoprotein inhibitor in Europe and globally. Also in October 2013, the FDA approved Aggrastat’s high-dose bolus regimen pursuant to a previous sNDA submission by the company. Since then, sales of Aggrastat in the USA 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$1.167m user fee paid by Medicure to the FDA.
The company’s subsidiary, Medicure International, Inc (Barbados) holds the rights to Aggrastat in the USA and its territories.