BioCentury
ARTICLE | Company News

Medicines Co. scores CHMP hat trick

January 24, 2015 2:16 AM UTC

EMA's CHMP recommended marketing authorization of three candidates from The Medicines Co. (NASDAQ:MDCO): Kengrexal cangrelor to reduce thrombotic cardiovascular events, Orbactiv oritavancin to treat acute bacterial skin and skin structure infections (ABSSSIs), and Raplixa as a supportive treatment to improve hemostasis where standard surgical techniques are insufficient.

Medicines Co. said CHMP based its approval of Kengrexal, a reversible purinergic receptor P2Y G protein-coupled 12 ( P2RY12; P2Y12) antagonist, on results from the 11,145-patient Phase III CHAMPION PHOENIX trial, in which Kengrexal followed by Plavix clopidogrel met the primary composite endpoint of reducing all-cause mortality, MI, ischemia-driven revascularization and stent thrombosis at 48 hours vs. clopidogrel alone in patients undergoing percutaneous coronary intervention (PCI). ...