CHMP recommendations for Kengrexal (cangrelor),Orbactiv (oritavancin) and Raplixa (sealant) from The Medicines Company
The Medicines Company 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). These positive opinion recommendations represent category firsts across three therapeutic areas: 1.Kengrexal is the first intravenous antiplatelet agent that provides immediate, consistent, and rapidly reversible P2Y12 inhibition; 2.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 3.Rapilxa is the first ready-to-use, biologically active, powdered fibrin sealant that provides hemostasis in a wide range of bleeding settings. Phase III study results for these new products have been published in the New England Journal of Medicine (Kengrexal and Orbactiv) and the Journal of the American College of Surgeons (Raplixa).
The Marketing Authorization Application (MAA) submission for Kengrexal to the EMA was based on the results from the CHAMPION PHOENIX trial which provided the primary evidence of efficacy for the proposed PCI indication for Kengrexal. The results of CHAMPION PHOENIX, an 11,145 patient Phase III randomized, double-blind clinical trial comparing Kengrexal to oral clopidogrel in patients undergoing PCI were reported in March 2013. Data from the CHAMPION pooled population of over 25,000 PCI patients provide additional clinical support for safety.
Comment: The European Medicines Agency is recommending that Kengrexal be used only in patients who cannot take generic P2Y12 inhibitors, such as Plavix (clopidogrel), which is a smaller indication than The Medicines Company initially sought.
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