Pharmaceutical company Chimerix reached an agreement with the U.S. Food and Drug Administration Tuesday to provide a 7-year-old boy with an experimental drug that could save his life.
The company initially refused to provide Josh Hardy with brincidofovir, which is still in the trial phase, because it said it had hundreds of such requests, which slowed down its efforts to study its effectiveness to treat adenovirus.
Josh was diagnosed with adenovirus in February after a bone marrow transplant left him with a weakened immune system. Since he was 9 months old, he has beat cancer, which over the years as shown up in his kidneys, thymus, lung and bone marrow.
Josh's mother, Aimee Hardy, said she didn't understand why Chimerix refused the treatment.
The company said it would start treating Josh with the drug Wednesday as part of a pilot trial of open-label brincidofovir.
"This 20-patient open-label study underscores Chimerix's mission to develop innovative antiviral therapies in areas of high unmet need -- for everyone," said Kenneth I. Moch, President & CEO of Chimerix. "Being unable to fulfill requests for compassionate use is excruciating, and not a decision any one of us ever wants to have to make. It is essential that each individual in a health crisis be treated with equal gravity and value, a principle we have upheld by pursuing further clinical study of brincidofovir that will inform its use in adenovirus and other serious DNA viral infections."
Josh is currently in an intensive care unit at a Memphis, Tenn., hospital.