CSL Behring announced that the FDA has accepted for standard review its Biologics License Application (BLA) for a human 4-factor prothrombin complex concentrate (PCC) for the urgent reversal of vitamin K-antagonist therapy (eg, warfarin) in patients with acute major bleeding.
The CSL Behring BLA submission is based on results from three prospective Phase 3 clinical trials that evaluated the safety and efficacy of PCC in patients who required urgent reversal of warfarin therapy. The pivotal, acute major bleeding trial demonstrated that PCC was comparable to plasma at 24 hours in patients who required urgent reversal of warfarin therapy (72.4% and 65.4%, respectively). Additionally, the co-primary efficacy endpoint analysis showed that the 4-factor PCC was superior in achieving target INR correction within 30 minutes at the end of infusion as compared to plasma (62.2% and 9.6%, respectively). Four-factor PCC was also superior to plasma in rapidly and safely raising the levels of clotting factors II, VII, IX, X, and anticoagulant Proteins C and S at the same 30 minutes post-treatment time point (P values<0.0001).
PCC are derived from human plasma. CSL Behring’s investigational PCC contains four important pro-coagulant factors in significant quantities: Factor II (prothrombin), Factor VII, Factor IX and Factor X, as well as anticoagulant Proteins C and S.
For more information, call (877) 236-4423 visit www.cslbehring.com.