FDA Requests Additional Information for Aggrastat
The FDA reviews Medicure Incâ€™s supplemental new drug application for Aggrastat.
The FDA has sent a complete response letter to Medicure and requested additional information before it could consider approving an expanded indication for Aggrastat for patients with ST segment elevation myocardial infarction (STEMI). Aggrastat is currently approved as a treatment to reduce the rate of thrombotic cardiovascular events in patients with non-ST elevation acute coronary syndrome.
Medicure provided data from the On-TIME 2 trial as the majority of its supporting evidence for Aggrastat’s expanded indication.
The manufacturer said it would work directly with the FDA to address their concerns.
The On-TIME 2 trial was a multicenter, prospective, randomized, controlled study that examined Aggrastat using the high-dose bolus (HDB) regimen, meaning 25 mcg/kg followed by a 0.15 mcg/kg/min maintenance infusion, in patients with STEMI planned for primary percutaneous coronary intervention (PCI).
In a pooled analysis, major adverse coronary events at 30 days was significantly reduced by Aggrastat compared with the control. The incidence of 30-day mortality was also reduced in the Aggrastat patients compared with the control, among those undergoing primary PCI and receiving a stent.
"We are evaluating the FDA's response and will work closely with the agency to address their comments," Albert Friesen, CEO and president of Medicure, said in a press release. "In the meantime, Aggrastat continues to be the fastest growing GPI [Glycoprotein IIb/IIIa Inhibitors] in the United States."
Medicure noted that the Aggrastat HDB regimen is recommended in the American College of Cardiology Foundation/American Heart Association/Society for Cardiovascular Angiography and Interventions guidelines.
The STEMI indication was approved in Europe based on the same clinical data sent to the FDA.