The Medicines Company receives CHMP positive opinions for Kengrexal, Orbactiv and Raplixa

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions recommending marketing authorization for three of US drugmaker The Medicines Company’s (Nasdaq: MDCO) development candidates – Kengrexal (cangrelor), Orbactiv (oritavancin) and Raplixa (sealant powder).

Kengrexal is the first intravenous antiplatelet agent that provides immediate, consistent, and rapidly reversible P2Y12 inhibition; Orbactiv is the first single-dose intravenous antibiotic for treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible designated Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA); and Raplixa is the first ready-to-use, biologically active, powdered fibrin sealant that provides hemostasis in a wide range of bleeding settings. The recommendations were supported by Phase III results.

Unmet needs in acute care