FDA Accepts the Filing of The Medicines Company's New Drug Application for Intravenous Antiplatelet Agent Cangrelor
PARSIPPANY, NJ -- (Marketwired) -- 07/01/13 -- The Medicines Company today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of the new drug application (NDA) for the Company's investigational intravenous antiplatelet cangrelor.
The filing was based on the results of a comprehensive development program, including the data from four randomized, double-blind clinical trials conducted in more than 25,000 patients with coronary artery disease (CHAMPION PHOENIX, CHAMPION PLATFORM, CHAMPION PCI, and BRIDGE). Cangrelor is intended for use in patients undergoing percutaneous coronary intervention (PCI) and those that require bridging from oral antiplatelet therapy to surgery.
"There is a specific need for better antiplatelet solutions in patients being treated in the acute care setting and the clinical trial development program offers a clear look at data surrounding cangrelor's utility as an antiplatelet therapy in these patients," said Robert A. Harrington, MD, professor and chair of the Department of Medicine at Stanford and co-principal investigator of the CHAMPION program.
"With filing of the NDA now complete, we will work closely with the FDA to advance the review process for cangrelor during the next 10 months," said Simona Skerjanec, PharmD, MBA, Senior Vice President and Innovation Leader for Antiplatelet Therapies at The Medicines Company. "If the review is successful, we anticipate U.S. market approval in the second quarter of 2014. We remain on track for an anticipated European submission in the fourth quarter 2013."
The other co-principal investigator for the CHAMPION program, Deepak L. Bhatt, MD, MPH, chief of cardiology at VA Boston Healthcare System and Director of the Integrated Interventional Cardiovascular Program at Brigham and Women's Hospital, as well as professor of medicine at Harvard Medical School, added, "There is a wealth of data in the CHAMPION trials and we will continue analyzing it for the generation of future presentations at international forums, including the upcoming European Society of Cardiology."
Cangrelor is an investigational agent not approved for commercial use in any market. Cangrelor, an immediately bioavailable and quickly reversible intravenous small molecule antiplatelet agent, is in development to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting including in patients undergoing PCI.
The results of CHAMPION PHOENIX, a 11,145 patient Phase 3 randomized, double-blind clinical trial comparing the Company's intravenous antiplatelet cangrelor to oral clopidogrel in patients undergoing PCI were reported in March 2013 and showed that patients treated with cangrelor had a 22% (p=0.005) reduced odds of experiencing the primary endpoint, which was a composite incidence of death, myocardial infarction (MI), ischemia-driven revascularization (IDR) or stent thrombosis (ST) at 48 hours after randomization. Cangrelor also showed a 38% reduction in the odds of the key secondary endpoint, incidence of stent thrombosis at 48 hours. An increase in the incidence of access site bleeding and transient dyspnea was observed with cangrelor.
In 2011, the Company also reported results of the BRIDGE trial, a prospective, randomized, double-blind, placebo-controlled multicenter trial which evaluated cangrelor or placebo in 210 patients with an acute coronary syndrome (ACS) or treated with a coronary stent that were at increased risk of thrombotic events following discontinuation of oral platelet inhibition prior to coronary artery bypass graft (CABG) surgery.
Study results demonstrated cangrelor maintained target levels of platelet inhibition known to be associated with a low risk of thrombotic events, such as stent thrombosis, compared to placebo (99%of cangrelor-treated patients vs. 19% placebo patients, p < 0.001) without increasing surgical bleeding complications.
About The Medicines Company
The Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and wellbeing of critically ill patients. The Medicines Company's website is www.themedicinescompany.com.
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates" and "expects" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include, whether the Company will make regulatory submissions for product candidates on a timely basis, whether the Company's regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed on May 9, 2013, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Source: The Medicines Company
Posted: July 2013
- FDA Advisory Committee Recommends Against Antiplatelet Therapy Cangrelor - February 12, 2014
- Totality of Data From Three Phase III Trials of The Medicines Company's Intravenous Cangrelor Presented and Published - September 3, 2013