FDA Lifts Clinical Hold on Pfizer Hemophilia A Gene Therapy Trial

The FDA lifted a clinical hold it had placed on Pfizer’s investigational Hemophilia A gene therapy giroctocogene fitelparvovec, which was being studied in a phase 3 clinical trial.

The agency placed the hold on the trial in November 2021 because several study participants demonstrated a substantial risk of blood clots.

Although the clinical hold has now been lifted, the company said it will pause the trial until “all necessary conditions are met,” which include the FDA approving updated study protocols.

Pfizer, along with its clinical trial partner, Sangamo Therapeutics, plan on resuming dosing in the clinical trial in the third quarter of this year.