Another of Pfizer’s gene therapies has been freed from an FDA clinical hold, but the study is not set to get underway immediately.
The FDA lifted its clinical hold of a phase 3 study called Affine for the hemophilia A gene therapy giroctocogene fitelparvovec in March. But Pfizer is maintaining a voluntary pause and will resume clinical activities in a few months, the company said during first quarter earnings Tuesday.
The voluntary pause will stay in place until Pfizer has met all necessary conditions, including approval of updated study protocols by regulatory authorities, the company said.
