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# FDA Lifts Hold on Pfizer Hemophilia A Gene Therapy
- URL: https://www.fdaweb.com/fda-lifts-hold-on-pfizer-hemophilia-a-gene-therapy/
- Published: 2022-05-03T12:00:00.000Z
- Updated: 2026-09-14T17:43:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151732

FDA has lifted a clinical hold on Pfizer’s giroctocogene fitelparvovec (Hemophilia A gene therapy), the company disclosed in a 5/3 earnings announcement. The hold was placed on the Phase 3 AFFINE study 11/3/2021 following observance of Factor VIII levels greater than 150% in some study participants. At the time, Pfizer [said](https://www.ehc.eu/pfizer-hemophilia-a-clinical-program-update%5Fnovember-5th-2021/?ref=fdaweb.com) it also paused the study to implement a protocol change to provide clinical management guidance for elevated Factor VIII levels.  

Pfizer now says the voluntary pause remains in place until all necessary conditions are met, including approval of updated study protocols by regulatory authorities. “Pfizer was recently made aware of an event of below-the-knee deep vein thrombosis in one trial participant with elevated Factor VIII levels,” the company says. “This patient had a history of thrombotic events prior to participation in the study, which is a known risk factor for subsequent events and an exclusion criterion for participation in AFFINE. The case was assessed to understand all potential contributing factors, including missed doses of investigator-prescribed direct oral anti-coagulants. The patient is reported to be doing well. The information was shared with study investigators, health authorities and the independent external data monitoring committee, and Pfizer responded to queries from health authorities.” It anticipates resuming dosing in the AFFINE trial in the third quarter.