(WMC-TV) - In some pictures, 7-year-old Josh Hardy boasts a big smile in sports jerseys, but the last three months in the intensive care unit at St. Jude Children's Hospital has replaced the eye black with tubes and gauze.
A company's decision Tuesday to provide drug access could be a game changer in the fight for Josh's life. Initially, Chimerix refused to give brincidofovir—a drug that might cure Josh's adenovirus infection—because the U.S. Food and Drug Administration had yet to approve it.
"They have given us excuses about challenging them financially, but we really don't care what excuses there are. They have something that can help our son, and we as parents are going to do everything we can possible do to help him. The thing is he's had a very challenged life," said mother Aimee Hardy Monday.
Josh has been fighting life-threatening illnesses since he was 9 months old, when he battled a rare kidney cancer called malignant rhabdoid tumor. Shortly after Josh was cured of the tumor, doctors discovered a pre-leukemia like cancer that required a bone marrow transplant; receiving treatment sent him to the ICU in January.
Aimee says her son's current infection—actively targeting his heart and kidney—would continue to move throughout his body without the drug. Josh gained national attention after the family's determination to gain a dosage.
In a news release, Chimerix announced they reached a deal with the FDA for the immediate initiation of a pilot trial of open-label brincidofovir for the treatment of adenovirus infections in immunocompromised patients.
"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," said Chimerix president and CEO Kenneth I. Moch.
Chimerix credited Josh's story for the acceleration of their discussion with the FDA concerning adenovirus patients. Aimee said the FDA may not approve the drug before 2016, which would have not been acceptable for her son.
St. Jude calls the drug experimental because it is not approved. The safety and effectiveness of the medication has not yet been established for use in children, according to a statement. They will administer it under a new treatment protocol as approved by a committee.
The hospital received the drug Wednesday.
A post on the #SaveJosh Facebook page thanked thousands of followers for support in addition to the employees and board members of Chimerix.