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Hold Lifted But Waiting

The US Food and Drug Administration lifted a clinical hold on another of Pfizer's gene therapy trials, though FierceBiotech reports that the company won't resume the study just yet.

It says Pfizer and Sangamo Therapeutics voluntarily paused their phase 3 study of the gene therapy giroctocogene fitelparvovec for hemophilia A after discovering that the treatment might increase the risk of blood clots. Hemophilia A is caused by a missing or defective factor VIII, a blood clotting factor. FierceBiotech notes that FDA then placed a clinical hold on the AFFINE trial in November 2021.

It now reports that FDA lifted that hold in March but that Pfizer and Sangamo have delayed the resumption of the trial until the third quarter of the year. The pause is to remain until the certain conditions are met, such as the regulatory approval of updated study protocols, according to FierceBiotech.

Last week, FDA also lifted a hold on Pfizer's Phase III CIFFREO trial of a gene therapy, fordadistrogene movaparvovec, for Duchenne muscular dystrophy. That trial, Genetic Engineering & Biotechnology News reports, was paused in August 2021 due to three adverse events, including two instance of myocarditis, before resuming in November, but paused again following a patient death. FierceBiotech notes that Pfizer has given an updated potency assay and changed its study protocol to include increased patient monitoring.

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