Pfizer Inc. appears closer to launching a gene therapy for hemophilia A, based on the positive results of the Phase III AFFINE study testing giroctocogene fitelparvovec for the treatment of moderately severe to severe hemophilia A versus prophylaxis.
The company announced the positive data on 24 July, reporting the AFFINE study met its primary endpoint of non-inferiority, as well as superiority, on total annualized bleeding rate (ABR) from week 12 through at least 15 months of follow up post-infusion compared with routine Factor VIII replacement prophylaxis treatment