|The Medicines Company Announces FDA Approval of KENGREAL™ (cangrelor) as an Adjunct to Percutaneous Coronary Intervention (PCI) for Reducing Thrombotic Events|
Novel intravenous antiplatelet agent adds to MDCO commercial offerings in the cardiac cath lab
Field force in place and product ready for supply in July
This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20150622006274/en/
KENGREAL(TM)(cangrelor)(Photo: Business Wire)
The Medicines Company expects KENGREAL to be available in the U.S. in July.
KENGREAL is the first and only intravenous, reversible P2Y12 platelet inhibitor with an immediate onset of action for patients undergoing PCI that, in clinical trials, has been shown to reduce the risk of periprocedural thrombotic events, including myocardial infarction, stent thrombosis, and repeat coronary revascularization.
“The approval of KENGREAL provides a new option for PCI,” said Clive A.
Meanwell, MD, PhD, Chairman and Chief Executive Officer, The
The CHAMPION PHOENIX study provided the primary evidence of efficacy for
the approval of KENGREAL™. The results of this trial, an 11,145 patient
Phase 3 randomized, double-blind clinical trial comparing KENGREAL to
oral clopidogrel in patients undergoing PCI, were published in
“In the U.S., the vast majority of PCI procedures are done on an ad hoc
basis because clinicians want to define the coronary anatomy prior to
making a treatment decision,” said
PCI, commonly known as coronary angioplasty, is a non-surgical procedure used to treat narrowed arteries found in coronary heart disease. More than 700,000 PCI procedures each year in the U.S. require effective antithrombin and antiplatelet therapy. KENGREAL has the potential to address the unmet needs of these patients and is well-suited for contemporary U.S. practice in the cath lab.
“I believe that intravenous cangrelor has the potential to substantially
improve outcomes for patients with cardiovascular disease because of its
immediate onset of near complete platelet inhibition with rapid
The Company will discuss this approval during a call on June 23rd at 8:30 am ET. The conference call will be available via phone and webcast. Dial-in information is listed below:
Replay is available from 11:30 am Eastern time following the conference call through July 1, 2015. To hear a replay of the call, dial +1 (855) 859-2056 (domestic) and +1 (404) 537-3406 (international). Passcode for both dial-in numbers is 69887586.
This call is being webcast and can be accessed via The
About KENGREAL™ (cangrelor)
KENGREAL, a synthetic, small molecule, is indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.
Important Safety Information
KENGREAL™ is contraindicated in patients with significant active bleeding.
KENGREAL™ is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to cangrelor or any component of the product.
Drugs that inhibit platelet P2Y12 function, including KENGREAL™, increase the risk of bleeding. In CHAMPION PHOENIX, bleeding events of all severities were more common with KENGREAL™ than with clopidogrel. Bleeding complications with KENGREAL™ were consistent across a variety of clinically important subgroups. Once KENGREAL™ is discontinued, there is no antiplatelet effect after an hour.
The most common adverse reaction is bleeding.
Please see full prescribing information for KENGREAL, available at http://www.kengreal.com.
About ANGIOMAX® (bivalirudin)
Angiomax® is indicated in patients undergoing PCI with provisional use of GPI and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is also indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. Angiomax is not approved for use in patients with acute coronary syndromes (ACS) not undergoing PCI or PTCA.
In clinical trials comparing Angiomax and heparin, the most common adverse reaction for Angiomax was bleeding (28%). Other common adverse reactions were headache, thrombocytopenia and fever. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax should be used with caution in patients with disease states associated with an increased risk of bleeding.
In gamma brachytherapy, an increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Angiomax. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components.
Please see full prescribing information for Angiomax, available at http://www.angiomax.com.
About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: serious infectious disease care, acute cardiovascular care and surgery and perioperative care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
Statements contained in this press release about The
The Medicines Company