The Chimerix pharmaceutical company said Tuesday that the ailing 7-year-old will receive medicine that doctors hope will help him when he becomes the first patient in a new trial set to start Wednesday.
Todd Hardy, Josh’s father, said he got the call from Chimerix president Kenneth Moch about a half hour before the public announcement was made.
“It was wonderful,” Hardy said. “Truly wonderful. It was overwhelming.”
In an emotional Facebook post, mother Aimee Hardy praised the company’s decision.
“Glory to GOD!” she wrote. “They are releasing the drug for Josh!!!!!!!!!”
The company had previously denied calls from the 7-year-old’s family to give him the drug, brincidofovir, arguing that spending the time to help Josh and others like him would slow down efforts to get the drug on the market.
Josh’s story drew national attention as his parents and supporters pushed the company to change its mind in online and media campaigns.
CNN told Josh’s story Sunday night, describing his parents’ desperate pleas for help from Chimerix.
Josh’s journey began when he was diagnosed with a rare form of kidney cancer at 9 months old. Over the years, cancer turned up in his thymus, lung, and bone marrow, and each time Josh beat it.
But a bone marrow transplant left Josh without much of an immune system, and in February doctors diagnosed him with an adenovirus that spread through his body.
Now he’s in critical condition in an intensive care unit as the virus ravages his body. Josh is in heart and kidney failure. He vomits blood several times an hour as his family gathers in vigil.
His doctors at St. Jude Children’s Research Hospital in Memphis had also been pushing for the company to provide the drug.
In a statement Tuesday, the hospital said it expected to receive the medication within 48 hours, but noted that its safety and effectiveness has not yet been established for use in children.
“It is also important to understand that this remains a critical and complex medical situation,” the hospital said.
“St. Jude will continue to pursue state-of-the-art treatment for Josh and all of our patients. We are grateful for the efforts of Chimerix, the FDA and many others who worked to achieve this outcome. We ask that you continue to keep Josh and his family in your thoughts.”
An FDA policy known as “compassionate use” allows someone with a serious or life-threatening disease to ask a drug company for an experimental drug.
Though it’s called compassionate use, sometimes it feels anything but compassionate.
Companies often say yes: The FDA approved 974 compassionate use arrangements in fiscal year 2013.
But pharmaceutical companies often say no, as Chimerix did at first to Josh Hardy.
Moch previously told CNN he wouldn’t back down from his decision not to give Josh the drug.
He said Tuesday that he hopes the new FDA-approved study will help other patients as well.
“I’m happy for Josh and I’m happy for many patients,” Moch said. “We’ve come up with a way of helping not just Josh, but helping other patients in need, and there are many.”
Over the past two years, the company has received more than 80 requests for compassionate use of brincidofovir from patients like Hardy, according to Moch.
Todd Hardy hailed Moch as a hero.
“He’s a super man. He worked diligently on behalf of everybody,” Hardy said. “His integrity was unquestioned. He was utterly professional.”
A Facebook page dedicated to the online campaign to help Josh get the medicine posted a thank-you message to supporters Tuesday night.
“Thank you to every member of Josh’s Army. The world has heard you and because of you Josh and many others will have the opportunity to receive CMX001 (Brincidofovir) the life saving antiviral drug made by Chimerix. ”
Past report by WREG-TV: