May 7 (Reuters) - A young boy died due to a cardiac
arrest in a mid-stage trial that tested Pfizer's ( PFE )
experimental gene therapy for a muscle-wasting disorder called
Duchenne muscular dystrophy (DMD), the drugmaker told Reuters on
Tuesday.
"A fatal serious adverse event was reported as cardiac
arrest for a participant in the Phase 2 DAYLIGHT study," a
company spokesperson told Reuters in an emailed response.
The trial tested boys 2 years to less than 4 years of age
with DMD, a genetic muscle wasting disorder in which most
patients lack the protein dystrophin which keeps muscles intact.
The disorder affects an estimated one-in-3,500 male births
worldwide.
"The patient received the investigational gene therapy,
fordadistrogene movaparvovec, in early 2023," as per a statement
from a community letter attributed to the drugmaker's DMD gene
therapy team and posted by a nonprofit advocacy group.
The company said, together with the independent external
data monitoring committee, it is in the process of reviewing the
data to understand the potential cause.