Pfizer is getting back to work on a late-stage test for its Duchenne muscular dystrophy (DMD) gene therapy. The decision comes several months after a patient death in a phase 1 trial drew a clinical hold on the medicine from the FDA.
The New York pharma disclosed the reactivation Thursday morning, announcing that the FDA had removed the clinical hold on fordadistrogene movaparvovec after the company addressed the agency’s requests regarding a potency assay and implemented a protocol amendment. The global phase 3 study called CIFFREO, which was paused in December 2021 when the death was revealed, will now get back underway in 11 countries.
