The Medicines Company
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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