Credit: Piotr Bodzek
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is recommending approval for the antiplatelet agent cangrelor (Kengrexal) and a hemostatic sealant powder to be marketed as Raplixa (formerly known as Fibrocaps).
Cangrelor is an intravenous antiplatelet agent that provides immediate and reversible P2Y12 inhibition. It is intended to prevent thrombosis in the acute care setting.
The sealant powder is a ready-to-use, biologically active, powdered fibrin sealant that provides hemostasis in a range of bleeding settings. It is intended for use in patients undergoing surgery.
Neither product has been approved for commercial use in any market, and both are under review by the US Food and Drug Administration as well as the European Medicines Agency/European Commission.
The European Commission generally follows CHMP recommendations for marketing authorizations and delivers its final decision within 3 months of the CHMP recommendation. Decisions are applicable to all 28 member states of the European Union, plus Iceland, Norway, and Liechtenstein.
About cangrelor
Cangrelor is intended to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting, particularly in patients undergoing percutaneous coronary intervention (PCI).
The CHMP is recommending cangrelor for European marketing authorization based on results from the CHAMPION PHOENIX trial, which was funded by the drug’s developer, The Medicines Company.
This phase 3, randomized, double-blind trial was a comparison of cangrelor and oral clopidogrel in 11,145 patients undergoing PCI.
In the initial analysis of the trial data, researchers found that cangrelor reduced the overall odds of complications from stenting procedures—including death, myocardial infarction, ischemia-driven revascularization, and stent thrombosis—compared to clopidogrel.
However, cangrelor also increased the risk of major and minor bleeding, as well as transient dyspnea.
Results of a second analysis suggested cangrelor can reduce the risk of stent thrombosis alone in patients undergoing PCI, when compared to clopidogrel. Cangrelor was an independent predictor of freedom from stent thrombosis at 30 days after PCI.
About Raplixa
This sealant powder is a mixture of 2 essential blood clotting proteins, fibrinogen and thrombin, formulated as a dry powder for topical use. It is intended to aid hemostasis during surgery.
The CHMP is recommending Raplixa (formerly Fibrocaps) for European marketing authorization based on results of the phase 3 FINISH-3 trial, which was funded by ProFibrix, Inc., the company that was developing the product at the time. (The Medicines Company recently purchased all the outstanding equity of ProFibrix.)
In this randomized, single-blind, controlled trial, researchers compared Raplixa administered with a gelatin sponge to the gelatin sponge alone as a hemostat for surgical bleeding in 4 indications: spinal, hepatic, vascular, and soft tissue dissection.
Raplixa significantly reduced the median time to hemostasis and the restricted mean time to hemostasis, compared with the gelatin sponge alone, for all 4 indications. Raplixa also significantly increased the probability of hemostasis at 3- and 5-minute time points.
The incidence of adverse events was generally similar between the treatment arms. However, non-neutralizing, anti-thrombin antibodies were slightly more common in the sponge-alone arm.
