Expanded label application for Aggrastat (tirofiban HCl) filed with FDA for ST segment elevation myocardial infarction -Medicure

Medicure has submitted a supplemental New Drug Application (sNDA) to the 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 to receive such a label in the United States.

The application is 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 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.

Comment: Medicure bought the US rights for Aggrastat from MGI Pharma in 2006 and the drug was selling well in the US where it is priced lower than competitors Reopro, Angiomax and Integrelin.