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Compassionate use of Chimerix drug denied for Josh Hardy

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Josh Hardy has been denied the compassionate use of a Chimerix drug that may help him fight a virus. CNN reports on March 10 that his family believes the brincidofovir medication made by the Chimerix company could save him. However, multiple attempts to obtain this drug have failed, and the company has refused to make an exception.

Hardy’s infection appeared after a bone marrow transplant, and other drugs have not been able to fight off the virus. Staff at St. Jude Children’s Research Hospital recommends brincidofovir and believes it may help Hardy’s case, but it has not been able to get the drug. Chimerix is still in the process of obtaining FDA approval for brincidofovir and has limited clinical trials. The company explains Hardy does not qualify for any of its current trials, and it cannot give him the medication based on compassionate use.

The 7-year-old is suffering from kidney failure and may not have much time left, yet the CEO of Chimerix, Kenneth Moch, shares there is nothing he can do to help. He explains the company cannot waste precious resources to comply with compassionate use requests because giving the drug to Hardy would mean giving it to many other people. Instead, Moch claims they are working on making the drug available to everyone by getting FDA approval. However, Hardy may not survive long enough to see the approval happen because Moch thinks brincidofovir could be available in several years.



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