Josh Hardy, treated with experimental Chimerix drug, is going home
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On The Web
Durham, N.C. — Chimerix, the Durham-based drug company working on experimental medicine that could save the life of a seven-year-old Josh Hardy, was granted approval by the U.S. Food and Drug Administration to administer the drug to the boy in March. On Wednesday, his mother said he is doing well and going home.
Aimee Hardy announced the news through her SaveJosh Facebook page, adding the family is returning home to Virginia.
“Glory to GOD! We are going home!!!! Leaving today. After 6 1/2 months, Josh finally gets to be in his house,” Aimee Hardy wrote.
The Facebook post noted that Josh does not need dialysis and he has improved heart function.
Her full post reads:
"Glory to GOD! We are going home!!!! Leaving today. After 6 1/2 months, Josh finally gets to be in his house.
"His Kidney function has returned and he is free of the need of Dialysis. His heart function is within normal range. His lung function is perfect. His tummy is coming around. He has not had the need of a blood transfusion in a month. And with a lot of hard work his strength will return. He can walk a nice distance holding my hands. And we anticipate the return of his immunity in a few months.
"John 14:13, 14~And I will do whatever you ask in my name, so that the Father may be glorified in the Son. You may ask me for anything in my name, and I will do it.
"GOD has answered our prayers!
"We do not have to be back in Memphis until 7/29. And after that appointment we should only have to come back to St Jude once a month until the one year mark in January.
"Thank you all for your love, support, and prayers.
The Back Story
Chimerix was granted approval by the U.S. Food and Drug Administration to administer the drug brincidofovir to the boy for compassionate use after a media campaign that included family appeals on Facebook and a CNN interview.
Josh was treated at St. Jude Children’s Research Hospital in Memphis, Tenn.
The company originally denied the Hardys because allowing brincidofovir to be used in Josh's treatment doing so could slow down the process of getting the drug to the market, they said.
"Being unable to fulfill requests for compassionate use is excruciating, and not a decision any one of us ever wants to have to make," said Kenneth Moch, president and CEO of Chimerix, in a statement. "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."
Brincidofovir has "the potential to become the first broad-spectrum antiviral for the prevention and treatment of clinically significant infections and diseases caused by DNA viruses," the company said.
Josh was the first patient in a pilot trial of the medicine.
The FDA allows someone with an immediate life-threatening illness to ask for permission to use experimental drugs that have not yet received the agency’s approval. Last year, the FDA approved 974 such requests, according to CNN.
"Our son will die without this drug," Josh's father, Todd, told CNN. "We're begging them to give it to us."
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