Medicure files supplemental new drug application to expand tirofiban hydrochloride labeling

Medicure submitted a supplemental new drug application with the FDA on Sept. 10 to expand the labeling for tirofiban hydrochloride (Aggrastat) to include patients with ST segment elevation myocardial infarction (STEMI).

The company said in a news release that it expects the FDA to make its approval decision by July 2016.

The medication, a glycoprotein IIb/IIIa Inhibitor, is currently approved to treat patients with non-ST segment elevation acute coronary syndrome.

Medicure said the FDA agreed to review the new indication based on data from the On-TIME 2 study and other research. The company noted that the safety and efficacy of the tirofiban hydrochloride high-dose bolus regimen to treat STEMI has been evaluated in more than 20 studies and more than 11,000 patients.

In the multicenter, prospective, randomized, controlled On-TIME 2 study, patients who received the tirofiban hydrochloride high-dose bolus regimen had a lower rate of major adverse cardiovascular events and mortality at 30 days.