The phase 3 AFFINE trial was paused voluntarily by the two partners almost a year ago, and subsequently placed on hold by the FDA, after patients treated with the therapy produced higher than expected levels of Factor VIII – the clotting factor that giroctocogene fitelparvovec is designed to produce in the body.
Some patients in the study saw Factor VIII activity greater than 150% following treatment, raising concerns that they may be at increased risk of harmful clotting events. Some patients were given oral anticoagulants to mitigate that risk.
