Von Willebrand disease product approved in Europe
Patients received vonicog alfa at 40-60 IU per kg of body weight 12-24 hours before surgery. Within 3 hours of surgery, each patient’s FVIII level (FVIII:C) was assessed, with a target of 30 IU/dL for minor surgeries and 60 IU/dL for major surgeries.
Within an hour of surgery, patients received a dose of vonicog alfa, with or without rFVIII, depending on the target FVIII:C levels at the 3-hour assessment.
A total of 10 patients received rVWF alone, 12 did not receive any preoperative rFVIII, and 2 did not receive rVWF postoperatively.
The study’s primary endpoint was met. Vonicog alfa demonstrated overall hemostatic efficacy, as assessed 24 hours after the last perioperative infusion or the completion of the study visit, whichever occurred earlier.
One patient developed deep vein thrombosis 3 days after undergoing hip replacement surgery; another tested positive for binding antibodies to VWF. None of the patients developed binding antibodies against potential impurities such as rFurin, CHO protein, or mouse IgG. These results were presented at the at the World Federation of Hemophilia World Congress in May 2018.
