Boy Who Got Unapproved Drug Heads Home to Virginia


But Dr. Hervé Momméja-Marin, Chimerix vice president of clinical research, said the drug has not been proven to do this in more advanced adenovirus cases, like Josh’s. Chimerix President and CEO Kenneth Moch said giving the drug to Josh would mean they would have to give the drug to the hundreds of other patients hoping to get it under the FDA's compassionate use rules, which allow patients to get drugs even if they aren’t enrolled in clinical trials.

"We all have great compassion for this child," Moch told March 11. "We spent our lives trying to develop new medications for patients just like Josh… We need to make sure to get this drug available as soon as possible to as many people as possible."

But the following day, Chimerix announced that Josh’s story accelerated talks with the Food and Drug Administration, allowing it to launch a 20-patient open-label clinical trial. Josh was the first patient enrolled.

Moch resigned from his position in April, Chimerix announced.

After months in the hospital, Josh was discharged in April. But persistent problems with his kidney, lung and heart function and the need for several blood transfusions kept the family in Tennessee. Now that those problems are resolved, the family can return to Fredericksburg, Virginia.

“And with a lot of hard work his strength will return,” Aimee Hardy wrote. “He can walk a nice distance holding my hands. And we anticipate the return of his immunity in a few months.”

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