The Medicines Co. (MDCO) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued positive opinions recommending marketing authorization for three of its pipeline 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 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.
A new drug application for ORBACTIV was approved by the United States Food and Drug Administration (FDA) in August 2014 after designation as a Qualified Infectious Disease Product (QIDP) under the U.S. Generating Antibiotic Incentives Now (GAIN) Act of 2012. Kengreal (cangrelor) and Raplixa new drug applications are under active review by the FDA.
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