UPDATE: The Medicines Co. Reminds Investors of FDA CRDAC Meeting Today, Says Proposing Cangrelor Be Indicated to Maintain P2Y12 Inhibition
The Medicines Company (NASDAQ: MDCO) announced today that NASDAQ has halted trading of the company's stock. The U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) is meeting today to discuss the new drug application (NDA) for cangrelor injection, for the proposed indication of reduction of thrombotic cardiovascular events including stent thrombosis (events related to blood clots in a stent, a device inserted to keep the artery open) in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI).
The Medicines Company is also proposing that cangrelor be indicated to maintain P2Y12 inhibition in patients with acute coronary syndromes or patients with stents who are at increased risk for thrombotic events (such as stent thrombosis) when oral P2Y12 therapy is interrupted due to surgery. P2Y12 is a protein involved in blood clotting; inhibiting this protein is a key mechanism of action of cangrelor.
The Advisory Committee meeting is scheduled for 7:30 a.m. ET. The briefing materials and webcast information can be found on the FDA website www.fda.gov.
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