FDA Reviews Aggrastat sNDA, Needs More Information for Expanded Indication
Medicure announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter for the supplemental New Drug Application (sNDA) of Aggrastat (tirofiban) for the expanded indication in patients with ST segment elevation myocardial infarction (STEMI).
The letter communicated that the Agency cannot approve the sNDA in its present form and is requesting additional information after the completion of the application's initial review.
The sNDA was supported by data from the On-TIME 2 study, a multi-center, prospective, randomized, controlled clinical trial evaluating the effect of Aggrastat high-dose bolus (HDB) regimen (25 mcg/kg followed by a 0.15 mcg/kg/min maintenance infusion) in patients with STEMI planned for primary PCI. Currently, no available Glycoprotein IIb/IIIa Inhibitors (GPI) are FDA-approved for STEMI in the US.
Medicure is reviewing the letter and plans to work closely with the FDA to address their comments.
Aggrastat is a GP IIb/IIIa inhibitor 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).
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