Pfizer Reports Topline Data from P-III Trial of Giroctocogene Fitelparvovec for Treating Hemophilia A
Shots:
- The P-III (AFFINE) trial assessed giroctocogene fitelparvovec (3e13vg/kg) in moderately severe to severe hemophilia A adult males (n=75); 50 subjects are from lead-in trial who have concluded FVIII replacement therapy for comparing with post-treatment data
- Study reached its 1EP, showing non-inferiority in total annualized bleeding rate (ABR) from wk.12 to min. 15mos. follow-up with 1.24 vs 4.73 reduction in mean total ABR
- 2EP was also reached, depicting 84% of them having FVIII activity >5% & most of them experiencing ≥15% at 15mos. after infusion with mean treated ABR reduction of 98.3% from 4.08 (pre-infusion) to 0.07 (post-infusion); 1.3% returned to prophylaxis after infusion. Further analysis is underway & will be discussed with regulatory authorities in the coming mos.
Ref: Pfizer | Image: Pfizer
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
