This week, Pfizer Inc. (NYSE: PFE) announced the unfortunate sudden death of a participant in a Phase II study for its investigational gene therapy, fordadistrogene movaparvovec, used to treat Duchenne muscular dystrophy (DMD). The patient, aged between 2 and 4 years, had received the treatment in the previous year.
In response to this incident, Pfizer has decided to temporarily pause dosing in a parallel late-stage trial for children aged 4 to 8 years. The company is collaborating with investigators, regulatory bodies, and an independent external data monitoring committee to thoroughly review and understand the circumstances surrounding the tragic event. Other studies involving fordadistrogene movaparvovec that have already completed dosing will not be impacted by this pause.- Flcube.com
